Drug recalls
Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.
17,975 records · source: openFDA Enforcement
All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class II | May 24, 2023 | VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care,… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for:… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for:… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for:… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care,… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care,… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for:… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care,… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC,… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care,… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium… | Lack of Assurance of Sterility | Apollo Care, LLC | Ongoing |
| Class II | May 24, 2023 | Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | ADMELOG Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only,… | Lack of Assurance of Sterility: Malformed crimped collar seal | Sanofi-Aventis U.S. LLC | Ongoing |
| Class II | May 24, 2023 | Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only,… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufactured for:… | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. | Terminated |
| Class II | May 24, 2023 | Heparin Sodium in Dextrose Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose… | Subpotent: Low anti-factor IIa Potency. | B. Braun Medical Inc | Terminated |
| Class II | May 17, 2023 | CALCITONIN SALMON Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL,… | Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable. | Apotex Corp. | Completed |
| Class III | May 17, 2023 | Gabapentin Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per… | Product mixup: one foreign tablet found in product. | The Harvard Drug Group | Terminated |
| Class I | May 17, 2023 | Atovaquone Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for:… | Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product… | Camber Pharmaceuticals Inc. | Ongoing |
| Class II | May 10, 2023 | Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer… | CGMP deviation: product outside labeled storage temperature requirements. | Family Dollar Stores, Llc. | Ongoing |
| Class I | May 10, 2023 | DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799… | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and… | Gadget Island, Inc | Ongoing |
| Class I | May 10, 2023 | Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health… | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and… | Gadget Island, Inc | Ongoing |
| Class I | May 10, 2023 | NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago,… | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and… | Gadget Island, Inc | Ongoing |
| Class II | May 10, 2023 | Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg… | CGMP deviation: product outside labeled storage temperature requirements. | Family Dollar Stores, Llc. | Ongoing |
| Class II | May 10, 2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a)… | CGMP deviation: product outside labeled storage temperature requirements. | Family Dollar Stores, Llc. | Ongoing |
| Class II | May 10, 2023 | Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets | CGMP deviation: product outside labeled storage temperature requirements. | Family Dollar Stores, Llc. | Ongoing |
| Class II | May 10, 2023 | Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By:… | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. | Terminated |
| Class II | May 10, 2023 | Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By:… | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. | Terminated |
| Class II | May 10, 2023 | Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx… | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. | Terminated |
| Class II | May 10, 2023 | Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By:… | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. | Terminated |
| Class II | May 10, 2023 | Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad… | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. | Terminated |
| Class III | May 10, 2023 | Lidocaine Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton… | Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect… | Bryant Ranch Prepack, Inc. | Ongoing |
| Class II | May 10, 2023 | Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net… | Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications | Seatex LLC | Ongoing |
| Class III | May 3, 2023 | Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5… | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc | Terminated |
| Class III | May 3, 2023 | Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1… | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc | Terminated |
| Class III | May 3, 2023 | Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container,… | Subpotent Drug: Out of specification results for low potency was obtained. | SCA Pharmaceuticals | Terminated |
| Class III | May 3, 2023 | Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk… | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc | Terminated |
| Class III | May 3, 2023 | Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1… | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc | Terminated |
| Class II | May 3, 2023 | CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays,… | Marketed Without an Approved NDA/ANDA | Wellness BioSciences | Ongoing |
| Class II | May 3, 2023 | Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile… | Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. | Sun Pharmaceutical Industries Ltd. | Terminated |
| Class II | May 3, 2023 | Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous… | CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not… | Methapharm Inc | Completed |
| Class II | May 3, 2023 | Tadalafil Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind… | CGMP Deviations | Northwind Pharmaceuticals LLC | Ongoing |
| Class II | May 3, 2023 | ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By:… | CGMP Deviations | Northwind Pharmaceuticals LLC | Ongoing |
| Class II | May 3, 2023 | Doxazosin Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind… | CGMP Deviations | Northwind Pharmaceuticals LLC | Ongoing |
| Class II | May 3, 2023 | Tadalafil Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b)… | CGMP Deviations | Northwind Pharmaceuticals LLC | Ongoing |
| Class II | May 3, 2023 | Glimepiride Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and… | CGMP Deviations | Northwind Pharmaceuticals LLC | Ongoing |
| Class II | May 3, 2023 | Buspirone Hydrochloride BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By:… | CGMP Deviations | Northwind Pharmaceuticals LLC | Ongoing |
| Class II | May 3, 2023 | Glimepiride Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b)… | CGMP Deviations | Northwind Pharmaceuticals LLC | Ongoing |
| Class II | May 3, 2023 | DIANEAL LOW CALCIUM WITH DEXTROSE Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II… | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. | Baxter Healthcare Corporation | Completed |
| Class II | May 3, 2023 | DIANEAL LOW CALCIUM WITH DEXTROSE Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged… | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. | Baxter Healthcare Corporation | Completed |
| Class II | April 26, 2023 | Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per… | CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation. | Pharma Nobis LLC | Ongoing |
| Class II | April 26, 2023 | C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South… | Lack of assurance of sterility. | Pharmacy Plus, Inc. dba Vital Care Compounder | Ongoing |
| Class II | April 26, 2023 | Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per… | Failed Dissolution Specifications: Out of specification dissolution results above specified values. | Amerisource Health Services LLC | Terminated |
| Class II | April 26, 2023 | Aripiprazole Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by:… | Out of specification (OOS) for Spectroscopic Identification test by IR. | Ascend Laboratories, LLC | Ongoing |
| Class III | April 19, 2023 | Norepinephrine Bitartrate Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop… | Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance… | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class III | April 19, 2023 | Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe,… | Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. | Pine Pharmaceuticals, LLC | Terminated |
| Class III | April 19, 2023 | MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array… | Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026;… | Pfizer Inc. | Ongoing |
| Class III | April 19, 2023 | Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only,… | Labeling; Incorrect NDC number on outer carton of product. | Focus Health Group Inc | Ongoing |
| Class II | April 19, 2023 | Pantoprazole Sodium Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only,… | CGMP Deviations: Discoloration | Hetero USA Inc | Ongoing |
| Class II | April 12, 2023 | Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals,… | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination. | Preferred Pharmaceuticals, Inc. | Terminated |
| Class II | April 12, 2023 | Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b)… | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination. | Preferred Pharmaceuticals, Inc. | Terminated |
| Class II | April 12, 2023 | Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b)… | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination. | Preferred Pharmaceuticals, Inc. | Terminated |
| Class II | April 12, 2023 | Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for:… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare,… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class III | April 12, 2023 | Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets,… | Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. | Teva Pharmaceuticals USA Inc | Terminated |
| Class II | April 12, 2023 | Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct… | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. | Direct Rx | Ongoing |
| Class II | April 12, 2023 | Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare,… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by:… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b)… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc.,… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b)… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc.,… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by:… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b)… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b)… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc.,… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b)… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc.,… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and… | cGMP Deviations | RemedyRepack Inc. | Terminated |
| Class II | April 12, 2023 | Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class III | April 12, 2023 | Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose… | Sub-potent drug: assay test result below specifications at 9-month timepoint. | Accord Healthcare, Inc. | Terminated |
| Class II | April 12, 2023 | Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b)… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs… | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. | Direct Rx | Ongoing |
| Class II | April 12, 2023 | Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct… | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer. | Direct Rx | Ongoing |
| Class II | April 12, 2023 | Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare,… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | testosterone cypionate Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL… | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. | Azurity Pharmaceuticals, Inc. | Terminated |
| Class II | April 12, 2023 | Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b)… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b)… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Tadalafil Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 12, 2023 | Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b)… | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. | Preferred Pharmaceuticals, Inc. | Ongoing |
| Class II | April 5, 2023 | Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium… | Lack of assurance of sterility: Suspected microbial growth present on external label packaging. | Apollo Care | Ongoing |
| Class II | April 5, 2023 | Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90,… | cGMP deviations | Direct Rx | Terminated |
| Class II | April 5, 2023 | Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC… | cGMP deviations | Direct Rx | Terminated |
| Class II | April 5, 2023 | Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90… | cGMP deviations | Direct Rx | Terminated |
| Class II | April 5, 2023 | Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC… | cGMP deviations | Direct Rx | Terminated |
| Class II | April 5, 2023 | Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC… | cGMP deviations | Direct Rx | Terminated |
| Class II | April 5, 2023 | Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC… | cGMP deviations | Direct Rx | Terminated |
| Class II | April 5, 2023 | Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC… | cGMP deviations | Direct Rx | Terminated |
| Class II | April 5, 2023 | Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle,… | cGMP deviations | Direct Rx | Terminated |
| Class II | April 5, 2023 | Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30;… | cGMP deviations | Direct Rx | Terminated |
| Class II | April 5, 2023 | Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC… | cGMP deviations | Direct Rx | Terminated |
| Class II | April 5, 2023 | Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC… | cGMP deviations | Direct Rx | Terminated |
| Class II | April 5, 2023 | Dabigatran Etexilate Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by:… | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. | Ascend Laboratories, LLC | Ongoing |
| Class II | April 5, 2023 | CALCITONIN SALMON Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200… | Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and… | Endo Pharmaceuticals, Inc. | Terminated |
| Class II | April 5, 2023 | Dabigatran Etexilate Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle,… | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. | Ascend Laboratories, LLC | Ongoing |
| Class I | March 29, 2023 | Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5… | Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria. | Global Pharma Healthcare Private Limited | Ongoing |
| Class III | March 29, 2023 | Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun… | Failed Content Uniformity Specifications | SUN PHARMACEUTICAL INDUSTRIES INC | Terminated |
| Class II | March 29, 2023 | Daytrana Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only,… | Defective Delivery System: Out of specification for shear. | Noven Pharmaceuticals Inc | Ongoing |
| Class II | March 29, 2023 | Daytrana Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only,… | Defective Delivery System: Out of specification for shear. | Noven Pharmaceuticals Inc | Ongoing |
| Class II | March 29, 2023 | Daytrana Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only,… | Defective Delivery System: Out of specification for shear. | Noven Pharmaceuticals Inc | Ongoing |
| Class II | March 29, 2023 | Daytrana Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only,… | Defective Delivery System: Out of specification for shear. | Noven Pharmaceuticals Inc | Ongoing |
| Class II | March 29, 2023 | Jardiance JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and… | Labeling: Label Mix-up | Boehringer Ingelheim Pharmaceuticals, Inc. | Terminated |
| Class II | March 22, 2023 | Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01),… | CGMP Deviations: Potential risk of Cross Contamination | Breckenridge Pharmaceutical, Inc | Terminated |
| Class III | March 22, 2023 | Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of… | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine… | AVEVA Drug Delivery Systems, Inc. | Terminated |
| Class II | March 22, 2023 | Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC… | CGMP Deviations: Potential risk of Cross Contamination | Breckenridge Pharmaceutical, Inc | Terminated |
| Class II | March 22, 2023 | Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC… | CGMP Deviations: Potential risk of Cross Contamination | Breckenridge Pharmaceutical, Inc | Terminated |
| Class II | March 22, 2023 | Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic… | Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity. | Teva Pharmaceuticals USA Inc | Terminated |
| Class III | March 22, 2023 | Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of… | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine… | AVEVA Drug Delivery Systems, Inc. | Terminated |
| Class II | March 22, 2023 | Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01)… | CGMP Deviations: Potential risk of Cross Contamination | Breckenridge Pharmaceutical, Inc | Terminated |
| Class III | March 22, 2023 | Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1… | Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not… | Padagis US LLC | Ongoing |
| Class II | March 22, 2023 | Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur… | CGMP Deviations: Potential risk of Cross Contamination | Breckenridge Pharmaceutical, Inc | Terminated |
| Class III | March 22, 2023 | Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b)… | Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing… | Zydus Pharmaceuticals (USA) Inc | Terminated |
| Class II | March 22, 2023 | Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur… | CGMP Deviations: Potential risk of Cross Contamination | Breckenridge Pharmaceutical, Inc | Terminated |
| Class II | March 15, 2023 | Heparin Sodium Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx… | Labeling: Not elsewhere classified | Sagent Pharmaceuticals Inc | Terminated |
| Class II | March 15, 2023 | Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz.… | CGMP DEVIATIONS | Ecometics, Inc. | Terminated |
| Class II | March 15, 2023 | Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles,… | CGMP Deviations | Pharmedica USA, LLC | Ongoing |
| Class II | March 15, 2023 | NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1%… | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation | Ongoing |
| Class I | March 15, 2023 | Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile… | Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits. | Nanomaterials Discovery Corporation | Ongoing |
| Class I | March 15, 2023 | Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9;… | Non-Sterility | Pharmedica USA, LLC | Ongoing |
| Class II | March 15, 2023 | NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL… | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation | Ongoing |
| Class II | March 15, 2023 | NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz(… | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation | Ongoing |
| Class II | March 15, 2023 | Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only,… | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. | Teva Pharmaceuticals USA Inc | Terminated |
| Class II | March 15, 2023 | NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for… | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation | Ongoing |
| Class II | March 15, 2023 | Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b)… | CGMP DEVIATIONS | Ecometics, Inc. | Terminated |
| Class II | March 15, 2023 | Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%,… | CGMP DEVIATIONS | Ecometics, Inc. | Terminated |
| Class II | March 15, 2023 | Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse… | CGMP DEVIATIONS | Ecometics, Inc. | Terminated |
| Class II | March 15, 2023 | Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars… | CGMP DEVIATIONS | Ecometics, Inc. | Terminated |
| Class II | March 15, 2023 | Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%,… | CGMP DEVIATIONS | Ecometics, Inc. | Terminated |
| Class II | March 15, 2023 | Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter… | CGMP DEVIATIONS | Denver Solutions, LLC DBA Leiters Health | Terminated |
| Class II | March 15, 2023 | Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796… | CGMP DEVIATIONS | Denver Solutions, LLC DBA Leiters Health | Terminated |
| Class II | March 15, 2023 | Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The… | CGMP DEVIATIONS | Ecometics, Inc. | Terminated |
| Class II | March 15, 2023 | Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796… | CGMP DEVIATIONS | Denver Solutions, LLC DBA Leiters Health | Terminated |
| Class II | March 15, 2023 | Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only,… | CGMP DEVIATIONS | Denver Solutions, LLC DBA Leiters Health | Terminated |
| Class III | March 15, 2023 | DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc.… | Labeling: Incorrect or Missing Lot and/or Exp Date | Akron Pharma, Inc. | Terminated |
| Class II | March 15, 2023 | Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per… | Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above… | Amerisource Health Services LLC | Terminated |
| Class II | March 15, 2023 | Brimonidine Tartrate Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper… | Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic… | Apotex Corp. | Completed |
| Class II | March 15, 2023 | Heparin Sodium in Dextrose Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose… | Subpotent Drug: low Anti-Factor IIa potency. | B. Braun Medical Inc | Terminated |
| Class II | March 8, 2023 | Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for:… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class III | March 8, 2023 | Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight… | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc | Terminated |
| Class II | March 8, 2023 | Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial,… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial,… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Montelukast Sodium Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class III | March 8, 2023 | Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight… | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc | Terminated |
| Class III | March 8, 2023 | BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross Weight 20.0… | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc | Terminated |
| Class II | March 8, 2023 | Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial,… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class III | March 8, 2023 | Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50… | Subpotent Drug | SCA Pharmaceuticals | Terminated |
| Class II | March 8, 2023 | Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class III | March 8, 2023 | Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight… | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | DuPont Nutrition USA, Inc | Terminated |
| Class II | March 8, 2023 | Doxazosin Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class I | March 8, 2023 | PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister… | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and… | Volt Candy Wholesale Club | Terminated |
| Class II | March 8, 2023 | Doxazosin Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Doxazosin Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL… | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC | Terminated |
| Class II | March 8, 2023 | Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial,… | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC | Terminated |
| Class II | March 8, 2023 | ropinirole rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Doxazosin Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32… | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC | Terminated |
| Class II | March 8, 2023 | ropinirole rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | ropinirole rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | ropinirole rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250… | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC | Terminated |
| Class II | March 8, 2023 | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16… | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC | Terminated |
| Class II | March 8, 2023 | ropinirole rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | ropinirole rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial,… | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC | Terminated |
| Class II | March 8, 2023 | Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64… | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC | Terminated |
| Class II | March 8, 2023 | Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial,… | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC | Terminated |
| Class II | March 8, 2023 | Finasteride Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | ropinirole rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | PRAVASTATIN SODIUM Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for:… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Rosuvastatin Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Buspirone Hydrochloride BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for:… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Dofetilide Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Rosuvastatin Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Aripiprazole Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Glycopyrrolate Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Buspirone Hydrochloride BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for:… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only,… | Packaging defect: observed packaging defect, blister packaging inadequately sealed. | The Harvard Drug Group | Terminated |
| Class II | March 8, 2023 | Sterile Water Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th… | CGMP Deviations: Potential product carryover. | Nephron Sc Inc | Terminated |
| Class II | March 8, 2023 | Pirfenidone Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Glimepiride Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Daptomycin Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by:… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Simvastatin Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15,… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Glimepiride Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Buspirone Hydrochloride BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for:… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Glycopyrrolate Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only,… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class III | March 8, 2023 | Gabapentin Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen… | Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in… | Sciegen Pharmaceuticals Inc | Terminated |
| Class II | March 8, 2023 | ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Glycopyrrolate Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Aripiprazole Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10,… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | PRAVASTATIN SODIUM Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Dofetilide Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | PRAVASTATIN SODIUM Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for:… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Tadalafil Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10,… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Daptomycin Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Simvastatin Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15,… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Rosuvastatin Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | Glimepiride Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |
| Class II | March 8, 2023 | ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC… | CGMP Deviations: recalling drug products following an FDA inspection. | Accord Healthcare, Inc. | Terminated |