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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
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class III September 16, 2026 Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper… Subpotent Drug ImprimisRx NJ LLC Ongoing
Class I September 16, 2026 Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation… Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution. Baxter Healthcare Corporation Ongoing
Class III September 16, 2026 FLUPHENAZINE HYDROCHLORIDE Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by:… Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the… Ajanta Pharma USA Inc Ongoing
Not Yet Classified September 16, 2026 fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl… Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry… OurPharma LLC Ongoing
Class II September 9, 2026 Nexterone Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container,… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 Trazodone Hydrochloride traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in… Presence of Foreign Tablets/Capsules Teva Pharmaceuticals USA, Inc Ongoing
Class II September 9, 2026 Vasopressin in 0.9% Sodium Chloride Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%,… Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on… Allies Group Inc. Ongoing
Class II September 9, 2026 PANTOPRAZOLE SODIUM Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL)… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%,… Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on… Allies Group Inc. Ongoing
Class II September 9, 2026 Clindamycin phosphate Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 Daptomycin in Sodium Chloride Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 VANCOMYCIN HYDROCHLORIDE Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL),… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 Clindamycin phosphate Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 CARDENE IV CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 Daptomycin in Sodium Chloride Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total,… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%,… Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on… Allies Group Inc. Ongoing
Class II September 9, 2026 VANCOMYCIN HYDROCHLORIDE Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 Vasopressin in 0.9% Sodium Chloride Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 Clindamycin phosphate Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC,… Cross Contamination with Other Products Sage Products, LLC Ongoing
Class II September 9, 2026 Famotidine Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 mycophenolate mofetil Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single… Failed Dissolution Specifications Mylan Pharmaceuticals Inc Ongoing
Class II September 9, 2026 Clindamycin phosphate Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 Clindamycin phosphate Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg… CGMP Deviations: Potential contamination of raw material Lexia LLC Ongoing
Class II September 9, 2026 THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%,… Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on… Allies Group Inc. Ongoing
Class II September 9, 2026 Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate… CGMP Deviations: Potential contamination of raw material Lexia LLC Ongoing
Class III September 9, 2026 Doxylamine Succinate and Pyridoxine Hydrochloride Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count… Presence of Foreign Tablets/Capsules Bionpharma Inc. Ongoing
Class I September 9, 2026 SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per… Presence of particulate matter: Particulates identified as fiberglass Baxter Healthcare Corporation Ongoing
Class III September 9, 2026 Buprenorphine Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed… Labeling: Label Mix-up American Health Packaging Ongoing
Class II September 9, 2026 Prasugrel Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS,… Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed… Golden State Medical Supply Inc. Ongoing
Class II September 9, 2026 Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4… CGMP Deviations Baxter Healthcare Corporation Ongoing
Class II September 9, 2026 Prasugrel Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan… Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria Mylan Pharmaceuticals Inc Ongoing
Class I September 9, 2026 Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione,… Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. OPTIMAL BALANCE PHARMACY Ongoing
Class III September 9, 2026 Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only,… Failed dissolution specifications. Supernus Pharmaceuticals, Inc. Ongoing
Class III September 9, 2026 Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx… Failed Stability Specifications: Out of specification stability result for the protein concentration profile. Chiesi USA, Inc. Ongoing
Not Yet Classified September 2, 2026 Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL… Cross Contamination with Other Products Safecor Health, LLC Ongoing
Class II September 2, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only,… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class II September 2, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only,… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class II September 2, 2026 Ramipril Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500… Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). Hikma Pharmaceuticals USA INC. Ongoing
Class II September 2, 2026 Acthar Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd.… Presence of particulate matter: glass and stopper piece Mallinckrodt Hospital Products Inc. Ongoing
Class II September 2, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only,… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class II September 2, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only,… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class II September 2, 2026 Clobetasol Propionate Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin… Failed content uniformity specifications. Lupin Pharmaceuticals Inc. Ongoing
Class II September 2, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class II September 2, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only,… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class II September 2, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class II September 2, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class II September 2, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class I September 2, 2026 TYENNE Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only,… Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. Fresenius Kabi USA, LLC Ongoing
Class I September 2, 2026 Lactated Ringers Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun… Presence of Particulate matter. B BRAUN MEDICAL INC Ongoing
Class II September 2, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only,… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class II September 2, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only,… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class II September 2, 2026 Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20… CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing Church & Dwight Co., Inc. Ongoing
Class II September 2, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only,… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class II September 2, 2026 Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only,… Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria Apotex Corp. Ongoing
Class I August 26, 2026 Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial… Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde American Regent, Inc. Ongoing
Class II August 26, 2026 nicardipine hydrochloride niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL… Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or… American Regent, Inc. Ongoing
Class II August 26, 2026 Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL… Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or… American Regent, Inc. Ongoing
Class II August 26, 2026 acetylcysteine ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION… Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or… American Regent, Inc. Ongoing
Class II August 26, 2026 PEMRYDI RTU PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only,… Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain… Shilpa Medicare Limited Ongoing
Class II August 26, 2026 PEMRYDI RTU PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only,… Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain… Shilpa Medicare Limited Ongoing
Class II August 26, 2026 acetylcysteine ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION… Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or… American Regent, Inc. Ongoing
Class II August 26, 2026 Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro… CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing SUN PHARMACEUTICAL INDUSTRIES INC Ongoing
Class II August 26, 2026 ATROPINE SULFATE Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1… Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or… American Regent, Inc. Ongoing
Class II August 26, 2026 Aminocaproic Acid AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE… Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or… American Regent, Inc. Ongoing
Class II August 26, 2026 Cyanocobalamin Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL… Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or… American Regent, Inc. Ongoing
Class II August 26, 2026 Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC… Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or… American Regent, Inc. Ongoing
Class II August 26, 2026 Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion… Lack of Assurance of Sterility Regeneron Pharmaceuticals Inc Ongoing
Class II August 26, 2026 Carbamazepine Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10),… CGMP deviations: tablets with black specks. Golden State Medical Supply Inc. Ongoing
Class II August 26, 2026 Cyanocobalamin Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only,… Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or… American Regent, Inc. Ongoing
Class II August 26, 2026 Acamprosate Calcium Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan… Failed Dissolution Specifications Mylan Pharmaceuticals Inc Ongoing
Class II August 26, 2026 Selenious Acid Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in… Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or… American Regent, Inc. Ongoing
Class II August 26, 2026 nitroglycerin Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC… Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or… American Regent, Inc. Ongoing
Class I August 26, 2026 Morphine Sulfate Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes,… Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. Fresenius Kabi USA, LLC Ongoing
Class II August 19, 2026 SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription… CGMP Deviations:Noted during FDA inspection Shoolin Pharma Chem LLP Ongoing
Class II August 19, 2026 SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Apollo Care, LLC Ongoing
Class II August 19, 2026 SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Apollo Care, LLC Ongoing
Class II August 19, 2026 SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Apollo Care, LLC Ongoing
Class II August 19, 2026 SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding… CGMP Deviations:Noted during FDA inspection Shoolin Pharma Chem LLP Ongoing
Class I August 19, 2026 Optiray Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound… Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. Liebel-Flarsheim Company LLC Ongoing
Class II August 19, 2026 SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only,… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Apollo Care, LLC Ongoing
Class I August 19, 2026 Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic… Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. Victory Medical Center Pharmacy Ongoing
Class II August 19, 2026 SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only,… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Apollo Care, LLC Ongoing
Class II August 19, 2026 SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Apollo Care, LLC Ongoing
Class II August 19, 2026 Diovan Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing… Failed Dissolution Specifications Novartis Pharmaceuticals Corporation Ongoing
Class I August 19, 2026 Kian Pee Wan Capsules, 30-count bottles Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine. Buy-Herbal Ongoing
Class II August 19, 2026 TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only",… CGMP Deviations:Noted during FDA inspection Shoolin Pharma Chem LLP Ongoing
Class II August 19, 2026 SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Apollo Care, LLC Ongoing
Class II August 19, 2026 SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only,… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Apollo Care, LLC Ongoing
Class II August 19, 2026 CLINDAMYCIN PALMITATE HYDROCHLORIDE CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL,… Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. Heritage Pharmaceuticals Inc Ongoing
Class II August 19, 2026 TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding… CGMP Deviations:Noted during FDA inspection Shoolin Pharma Chem LLP Ongoing
Class II August 19, 2026 SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Apollo Care, LLC Ongoing
Class II August 19, 2026 SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Apollo Care, LLC Ongoing
Class II August 19, 2026 SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous… Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Apollo Care, LLC Ongoing
Class II August 19, 2026 TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only",… CGMP Deviations:Noted during FDA inspection Shoolin Pharma Chem LLP Ongoing
Class I August 19, 2026 Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in… Presence of Particulate Matter Baxter Healthcare Corporation Ongoing
Class II August 19, 2026 CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist.… Lack of assurance of sterility. The recall is due to potential contamination Prestige Brands Holdings Ongoing
Class II August 12, 2026 Dicyclomine Hydrochloride Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by:… shortfill; reports of empty capsules. Aurobindo Pharma USA Inc Ongoing
Class I August 12, 2026 Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only,… Presence of Particulate Matter; identified as stainless steel Sunny Pharmtech Inc. Ongoing
Class I August 12, 2026 Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only,… Presence of Particulate Matter; identified as stainless steel Sunny Pharmtech Inc. Ongoing
Class III August 12, 2026 Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific),… Incorrect Product Formulation Central Admixture Pharmacy Services Inc Ongoing
Class II August 12, 2026 Mirabegron Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by:… CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. Zydus Pharmaceuticals (USA) Inc Ongoing
Class III August 5, 2026 Dabigatran Etexilate Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a… Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II,… Ascend Laboratories, LLC Ongoing
Class II August 5, 2026 azelaic acid Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by:… CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or… Glenmark Pharmaceuticals Inc., USA Ongoing
Class II August 5, 2026 Dorzolamide Hydrochloride and Timolol Maleate ophthalmic Solution Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx… Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. MICRO LABS USA INC Ongoing
Class III August 5, 2026 Dabigatran Etexilate Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a… Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II,… Ascend Laboratories, LLC Ongoing
Class III August 5, 2026 Dabigatran Etexilate Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a… Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II,… Ascend Laboratories, LLC Ongoing
Class II August 5, 2026 mycophenolate mofetil Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per… Presence of precipitate MYLAN PHARMACEUTICALS INC Ongoing
Class II July 29, 2026 Xylocaine Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25… Presence of Particulate Matter: Hair was found in products Fresenius Kabi USA, LLC Ongoing
Class II July 29, 2026 Divalproex Sodium Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only,… Presence of Foreign Tablets/Capsules Bionpharma Inc. Ongoing
Class II July 29, 2026 Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80… Lack of Assurance of Sterility Rohto-Mentholatum (Vietnam) Co., Ltd. Ongoing
Class II July 29, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose… Subpotent Drug Major Pharmaceuticals Ongoing
Class II July 29, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose… Subpotent Drug Major Pharmaceuticals Ongoing
Class II July 29, 2026 Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%),… Lack of Assurance of Sterility Rohto-Mentholatum (Vietnam) Co., Ltd. Ongoing
Class II July 29, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose… Subpotent Drug Major Pharmaceuticals Ongoing
Class II July 29, 2026 Cyproheptadine Hydrochloride Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only,… Presence of Precipitate: medication was crystallizing and particles floating in the bottle Rising Pharma Holding, Inc. Ongoing
Class II July 29, 2026 Naropin Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL),… Presence of Particulate Matter: Hair was found in products Fresenius Kabi USA, LLC Ongoing
Class II July 29, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose… Subpotent Drug Major Pharmaceuticals Ongoing
Class II July 29, 2026 Glycopyrrolate Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL… Presence of Particulate Matter: Hair was found in product Fresenius Kabi USA, LLC Ongoing
Class II July 29, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose… Subpotent Drug Major Pharmaceuticals Ongoing
Class II July 29, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose… Subpotent Drug Major Pharmaceuticals Ongoing
Class II July 29, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose… Subpotent Drug Major Pharmaceuticals Ongoing
Class I July 29, 2026 Cetirizine Hydrochloride Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique… Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed… JB Chemicals and Pharmaceuticals Ltd Ongoing
Class II July 29, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose… Subpotent Drug Major Pharmaceuticals Ongoing
Class II July 29, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose… Subpotent Drug Major Pharmaceuticals Ongoing
Class II July 29, 2026 Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80… Lack of Assurance of Sterility Rohto-Mentholatum (Vietnam) Co., Ltd. Ongoing
Class II July 29, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose… Subpotent Drug Major Pharmaceuticals Ongoing
Class II July 29, 2026 Lidocaine Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5… Presence of Particulate Matter: Hair was found in products Fresenius Kabi USA, LLC Ongoing
Class II July 29, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose… Subpotent Drug Major Pharmaceuticals Ongoing
Class II July 29, 2026 Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%,… Lack of Assurance of Sterility Rohto-Mentholatum (Vietnam) Co., Ltd. Ongoing
Class III July 29, 2026 Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only,… Failed Dissolution Specifications Supernus Pharmaceuticals, Inc. Ongoing
Class II July 29, 2026 Amlodipine and Olmesartan Medoxomil Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only,… Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications Ascend Laboratories, LLC Ongoing
Class III July 29, 2026 Dabigatran Etexilate Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by:… Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with… Ascend Laboratories, LLC Ongoing
Class II July 29, 2026 Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc… Lack of Assurance of Sterility Rohto-Mentholatum (Vietnam) Co., Ltd. Ongoing
Class II July 29, 2026 Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN… Lack of Assurance of Sterility Rohto-Mentholatum (Vietnam) Co., Ltd. Ongoing
Class II July 29, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose… Subpotent Drug Major Pharmaceuticals Ongoing
Class II July 29, 2026 Glycopyrrolate Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose,… Failed Impurities/Degradation Specifications Precision Dose Inc. Ongoing
Class III July 29, 2026 Dabigatran Etexilate Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by:… Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with… Ascend Laboratories, LLC Ongoing
Class II July 29, 2026 Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL… Lack of Assurance of Sterility Rohto-Mentholatum (Vietnam) Co., Ltd. Ongoing
Class II July 29, 2026 Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90,… Lack of Assurance of Sterility Rohto-Mentholatum (Vietnam) Co., Ltd. Ongoing
Class III July 29, 2026 Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single… Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan Asclemed USA Inc. Ongoing
Class II July 29, 2026 Xylocaine Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25… Presence of Particulate Matter: Hair was found in products Fresenius Kabi USA, LLC Ongoing
Class II July 22, 2026 Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01,… SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Bell Pharmaceuticals, Inc Ongoing
Class II July 22, 2026 QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included… SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Bell Pharmaceuticals, Inc Ongoing
Class II July 22, 2026 Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL)… SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Bell Pharmaceuticals, Inc Ongoing
Class II July 22, 2026 FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included,… SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Bell Pharmaceuticals, Inc Ongoing
Class II July 22, 2026 AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb… SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Bell Pharmaceuticals, Inc Ongoing
Class II July 22, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the… CareFusion 213, LLC Ongoing
Class II July 22, 2026 CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34,… SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Bell Pharmaceuticals, Inc Ongoing
Class II July 22, 2026 CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.);… SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Bell Pharmaceuticals, Inc Ongoing
Class II July 22, 2026 Cleviprex CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use… Lack of Assurance of Sterility Chiesi USA, Inc. Ongoing
Class II July 22, 2026 Nystatin Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube,… Subpotent Drug: Low out of specification assay results performed during long-term stability testing. Padagis US LLC Ongoing
Class II July 22, 2026 GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb… SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Bell Pharmaceuticals, Inc Ongoing
Class II July 22, 2026 meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC… SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Bell Pharmaceuticals, Inc Ongoing
Class II July 22, 2026 TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS… SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Bell Pharmaceuticals, Inc Ongoing
Class II July 22, 2026 LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL… SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Bell Pharmaceuticals, Inc Ongoing
Class II July 15, 2026 Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco… Subpotent drug Gasco Industrial Corp. Ongoing
Class II July 15, 2026 Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or… Lack of Sterility Assurance Reliance Life Sciences Private Limited Ongoing
Class II July 15, 2026 Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous… Lack of Sterility Assurance Reliance Life Sciences Private Limited Ongoing
Class II July 15, 2026 Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded… Failed Impurities/Degradation Specifications QuVa Pharma, Inc. Ongoing
Class II July 15, 2026 Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous… Lack of Sterility Assurance Reliance Life Sciences Private Limited Ongoing
Class II July 15, 2026 Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline… Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. BioMed Laboratories, LLC. Ongoing
Class II July 15, 2026 Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco… Subpotent drug Gasco Industrial Corp. Ongoing
Class II July 15, 2026 Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For… Lack of Sterility Assurance Reliance Life Sciences Private Limited Ongoing
Class II July 15, 2026 Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo… Subpotent drug Gasco Industrial Corp. Ongoing
Class II July 15, 2026 Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1… cGMP deviations Shimoga Chemicals Ongoing
Class II July 15, 2026 Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by:… Subpotent drug Gasco Industrial Corp. Ongoing
Class II July 15, 2026 Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by:… Subpotent drug Gasco Industrial Corp. Ongoing
Class II July 15, 2026 Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed… Subpotent drug Gasco Industrial Corp. Ongoing
Class II July 15, 2026 Methohexital Sodium Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured… Failed Impurities/Degradation Specifications ONESOURCE SPECIALTY PHARMA LIMITED Ongoing
Class II July 8, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and… CareFusion 213, LLC Ongoing
Class II July 8, 2026 ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and… CareFusion 213, LLC Ongoing
Class II July 8, 2026 Levothyroxine Sodium Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only,… Subpotent Drug ACCORD HEALTHCARE, INC. Ongoing
Class II July 8, 2026 CINACALCET Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla… cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Cipla USA, Inc. Ongoing
Class II July 8, 2026 IMULDOSA IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial,… Lack of assurance of Sterility: ACCORD BIOPHARMA INC Ongoing
Class II July 8, 2026 Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose… Lack of Assurance of Sterility Asclemed USA Inc. Ongoing
Class II July 8, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol… Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and… CareFusion 213, LLC Ongoing
Class II July 8, 2026 prednisolone acetate prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC… Presence of Foreign Substance Lupin Pharmaceuticals Inc. Ongoing
Class II July 8, 2026 BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and… CareFusion 213, LLC Ongoing
Class II July 8, 2026 CINACALCET Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla… cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Cipla USA, Inc. Ongoing
Class II July 8, 2026 BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and… CareFusion 213, LLC Ongoing
Class II July 8, 2026 CINACALCET Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla… cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Cipla USA, Inc. Ongoing
Class II July 8, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and… CareFusion 213, LLC Ongoing
Class II July 8, 2026 BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and… CareFusion 213, LLC Ongoing
Class II July 8, 2026 Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets),… CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production… Boehringer Ingelheim Pharmaceuticals, Inc. Ongoing
Class II July 8, 2026 TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle,… CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry Blaine Labs Inc Ongoing
Class II July 8, 2026 BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol… Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and… CareFusion 213, LLC Ongoing
Class II July 8, 2026 Lidocaine Hydrochloride Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed… Lack of Assurance of Sterility Asclemed USA Inc. Ongoing
Class II July 8, 2026 BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and… CareFusion 213, LLC Ongoing
Class I July 8, 2026 Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL)… Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other… Blaine Labs Inc Ongoing
Class II July 8, 2026 vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By:… CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry Blaine Labs Inc Ongoing
Class II July 8, 2026 TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6… CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be… Blaine Labs Inc Ongoing
Class II July 8, 2026 TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6… CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry Blaine Labs Inc Ongoing
Class II July 8, 2026 TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured… CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry Blaine Labs Inc Ongoing
Class II July 8, 2026 GEMCITABINE Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For… Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a… McKesson Ongoing
Class II July 8, 2026 Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz… CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry Blaine Labs Inc Ongoing
Class II July 8, 2026 Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as… CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be… Blaine Labs Inc Ongoing
Class II July 8, 2026 BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol)… Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and… CareFusion 213, LLC Ongoing
Class III July 8, 2026 Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle,… Failed Impurities/Degradation Specifications SUN PHARMACEUTICAL INDUSTRIES INC Ongoing
Class II July 8, 2026 Glucagon Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial,… CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability… Lupin Pharmaceuticals Inc. Ongoing
Class II July 8, 2026 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine… Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. Lannett Company Inc. Ongoing
Class II July 1, 2026 Lacosamide Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt.,… Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of… Annora Pharma Private Limited Ongoing
Class II July 1, 2026 Corlanor Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC… Presence of Foreign Substance. Amgen, Inc. Ongoing
Class II July 1, 2026 Methylergonovine Maleate Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10),… Subpotent Drug The Harvard Drug Group LLC Ongoing
Class II July 1, 2026 PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC,… Lack of Assurance of Sterility PReye LLC Ongoing
Class II July 1, 2026 Fenofibrate Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma… CGMP Deviations Ajanta Pharma USA Inc Ongoing
Class II July 1, 2026 Corlanor Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand… Presence of Foreign Substance. Amgen, Inc. Ongoing
Class II July 1, 2026 Sensipar Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One… CGMP Deviations Amgen, Inc. Ongoing
Class II July 1, 2026 DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60… CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Direct Rx Ongoing
Class II July 1, 2026 Perampanel Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries… Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg… SUN PHARMACEUTICAL INDUSTRIES INC Ongoing
Class II July 1, 2026 Sensipar Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One… CGMP Deviations Amgen, Inc. Ongoing
Class III July 1, 2026 Hydroxyzine Hydrochloride hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only,… Presence of foreign substance ANI Pharmaceuticals, Inc. Ongoing
Class I July 1, 2026 BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… Non-Sterility: Due to presence of Aspergillus penicillioides. CareFusion 213, LLC Ongoing
Class II July 1, 2026 BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. CareFusion 213, LLC Ongoing
Class II July 1, 2026 Sensipar Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One… CGMP Deviations Amgen, Inc. Ongoing
Class I July 1, 2026 BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl… Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in… CareFusion 213, LLC Ongoing
Class II July 1, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. CareFusion 213, LLC Ongoing
Class II July 1, 2026 Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346… sub potency Elevate Oral Care Ongoing
Class II July 1, 2026 Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx#… Incorrect product formulation: bag did not contain copper and famotidine per label. Central Admixture Pharmacy Services, Inc. Ongoing
Class II June 24, 2026 DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured… Defective container:may contain bottles with incomplete seals Keystone Industries Ongoing
Class II June 24, 2026 Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units),… CGMP Deviations; deficiencies observed during FDA inspection Dabur India Limited Ongoing
Class II June 24, 2026 Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield… CGMP Deviations; deficiencies observed during FDA inspection Dabur India Limited Ongoing
Class II June 24, 2026 VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated… Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 PAI Holdings LLC Ongoing
Class II June 24, 2026 Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net… Defective container:may contain bottles with incomplete seals Keystone Industries Ongoing
Class II June 24, 2026 Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg,… CGMP Deviations; deficiencies observed during FDA inspection Dabur India Limited Ongoing
Class II June 24, 2026 Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for:… CGMP Deviations; deficiencies observed during FDA inspection Dabur India Limited Ongoing
Class II June 24, 2026 Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin… CGMP Deviations; deficiencies observed during FDA inspection Dabur India Limited Ongoing
Class II June 24, 2026 Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for:… CGMP Deviations; deficiencies observed during FDA inspection Dabur India Limited Ongoing
Class II June 24, 2026 Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield… CGMP Deviations; deficiencies observed during FDA inspection Dabur India Limited Ongoing
Class III June 24, 2026 Focalin Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx… Labeling: Incorrect or Missing Lot and/or Exp Date Sandoz Inc Ongoing
Class II June 24, 2026 VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated… Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 PAI Holdings LLC Ongoing
Class II June 24, 2026 VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated… Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 PAI Holdings LLC Ongoing
Class II June 24, 2026 PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor,… Defective container:may contain bottles with incomplete seals Keystone Industries Ongoing
Class II June 24, 2026 Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5… CGMP Deviations; deficiencies observed during FDA inspection Dabur India Limited Ongoing
Class II June 24, 2026 Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL),… Defective container:may contain bottles with incomplete seals Keystone Industries Ongoing
Class II June 24, 2026 Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel… CGMP Deviations; deficiencies observed during FDA inspection Dabur India Limited Ongoing
Class II June 24, 2026 Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz… Defective container:may contain bottles with incomplete seals Keystone Industries Ongoing
Class II June 24, 2026 VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated… Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 PAI Holdings LLC Ongoing
Class II June 24, 2026 Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding… Subpotent Drug IntegraDose Compounding Services LLC Ongoing
Class II June 24, 2026 ALYACEN 1/35 Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg,… Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total… Glenmark Pharmaceuticals Inc., USA Ongoing
Class II June 24, 2026 Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box,… CGMP Deviations; deficiencies observed during FDA inspection Dabur India Limited Ongoing
Class II June 24, 2026 Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units,… CGMP Deviations; deficiencies observed during FDA inspection Dabur India Limited Ongoing
Class II June 24, 2026 Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case,… CGMP Deviations; deficiencies observed during FDA inspection Dabur India Limited Ongoing
Class II June 24, 2026 safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz.… Defective container:may contain bottles with incomplete seals Keystone Industries Ongoing
Class II June 24, 2026 Buprenorphine Hydrochloride Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx… Crystallization; identified as Buprenorphine free base Par Health USA, LLC Ongoing
Class II June 24, 2026 Aripiprazole Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA… Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP… Ajanta Pharma USA Inc Ongoing
Class II June 24, 2026 Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g),… Defective container:may contain bottles with incomplete seals Keystone Industries Ongoing