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 II	August 31, 2022	Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559; TYLENOL CHILD GRAPE 4 FL OZ SKU…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	DRX FIBER CAPSULES 100 CT distributed to specific Family Dollar Stores 04/30/2022 through…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	AFRIN NO DRIP SEVERE CONGESTION 0.5FL OZ distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	MIDOL COMPLETE CAPLET 16 CT SKU 913028 QP MENSTRUAL RELIEF COMPLETE CAPLET 16CT SKU…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	HYLANDS 4KIDS COLD N MUCUS RELIEF 4 FL OZ distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	VASELINE ECZEMA CALMING THERPY CRM 6.8 OZ distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	NPX ENEMA 4.5 FL OZ 2 PK distributed to specific Family Dollar Stores 04/30/2022 through…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	LIDOCAINE ARTHRITIS AND SPORT WNTGRN 16 FLOZ distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	Orajel Cold Sore Pain Cream 1.25 fl. oz. distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167 distributed…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	DOCTOR DANDRUF 2N1 SHAMP CLN APL 13.5FLOZ SKU 2005726 SUAVE 2N1 MENS CC ANTI DNDRF SHMP…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	MYLANTA MAX STRENGTH CLASSIC FLVR 12 FLOZ distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	DESITIN CREAMY OINTMENT 2 FL OZ SKU 912976 BABY LOVE OINTMENT CREAM 4 OZ SKU 902617…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	COLGATE MAX FRESH CLEAN MINT 1.9OZ SKU 900596 COLGATE CAVITY PROTECTION 6OZ 3PK SKU…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	CARMEX DAILY CARE CHERRY SPF 15 0.35 OZ SKU 901842 CARMEX LIP BALM JAR 0.25OZ SKU 903284…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30/2022…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	GUARDIAN BISMUTH CHWBLE CHRY TABS 30 CTSKU 902321 RIC BISMUTH MAXIMUM STRENGTH 8 FL OZ…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	SWAN PETROLEUM JELLY 7.5 OZ SKU 910721 BABY LOVE PETROLEUM JELLY 13 OZ SKU 910726…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	FLEET GLYCERIN SUPPOSITORIES 50 CT distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	GS ANTI DIARRHEAL LOPERAMIDE CAPLET 12 CT SKU 915632 IMODIUM AD MINT 4 OZ SKU 902080…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	DOCTOR TEALS PURE EPSOM SALT UNSCENTED 6 LBS SKU 999355 Ready in case EPSOM SALTS 2 LB…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores 04/30/2022…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	BLISTEX LIP MEDEX 0.25OZ SKU 906120 BLISTEX LIP MEDEX POT 0.38 OZ SKU 998852 distributed…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	VICKS VAPOCOOL DROPS SEVERE 18 CT SKU 999488 BEST HEALTH HONEY LEMON COUGH DROP 80 CT SKU…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT distributed to specific Family Dollar…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	CLARITIN ALLERGY LIQ CHLDRNS GRAPE 2 FLOZ SKU 900834 CLARITIN ALLERGY 10MG TABLETS 5 CT…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	DR SCHOLLS ANTI FUNGAL SPRAY PWDER 4.7 OZ SKU 998250 PREMIER ANTFGL TLNFTT LQ SPRY 5.3 FL…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	VICKS VAPORUB 1.76 OZ SKU 919667 VICKS VAPOR RUB LAVENDER 1.76 OZ 999813 SWAN MEDICATED…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	READY IN CASESLEEP AID SOFT GEL 32 CT SKU 901457 READY IN CASE SLEEP AID 64 CT SKU 999026…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	ORAJEL NON MED TEETHING GEL 0.125 OZ distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	SWAN POVIDONE 4 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	FW ASPIRIN CHEWABLE TABLET 36CT SKU 913990 GS ENTERIC ASPIRIN TABLET 120 CT SKU 913724…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	READY IN CASE PAIN RELIEVER PM CAPLET 100 CT SKU 902381 GOOD SENSE PAIN RELIEVER APAP…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	GOOD SENSE SORE THROAT SPRAY CHERRY 6 FL OZ distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	BC POWDER 50 CT SKU 901588 BC POWDER 18 CT SKU 913228 GOODYS POWDER 50 CT SKU 901589…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	DISNEY LICENSED ANTI BAC WIPES 20 CT SKU 998908; ANTIBACTERIAL WIPES 40CT SKU 2007538…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	GOOD SENSE LICE SHAMPOO 6FL OZ distributed to specific Family Dollar Stores 04/30/2022…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	STYE EYE OINTMENT 0.125 OZ distributed to specific Family Dollar Stores 04/30/2022…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	ALEVE ANALGESIC BACK MUSCLE 24 CT SKU 999787 ALEVE PM CAPLETS 20 CT SKU 900442 ALEVE…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	MOTRIN IB CAPLETS 24CT SKU999394; GOOD SENSE IBUPROFEN 200MG TABLETS 24CT SKU 900556;GOOD…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT SKU 900854 RIC…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	READY IN CASE RUBBING ALCOHOL 91 PCT 16 FL OZ SKU 902270 READY IN CASE 70 PCT ISOPROPYL…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	ARTHRITIS HOT CREME 3 OZ SKU 901452 ICY HOT PATCH 1 CT SKU 911030 ICY HOT MUSCLE RUB 1.25…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	PREVACID 24HR LANSOPRAZOLE 15MG CAP 14CT distributed to specific Family Dollar Stores…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	NPX TRIPLE ANTIBIOTIC OINTMENT 1 OZ SKU 910320 NPX PAIN ITCH SCAR ANTIBAC OINTMENT 1 OZ…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	ASPERCREME WITH LIDOCAINE CREME 1.75 OZ SKU 999852 ICY HOT LIDOCAINE CREAM 1.75 OZ SKU…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	JET ALERT TABLET 30 CT distributed to specific Family Dollar Stores 04/30/2022 through…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	MY CHOICE LEVONORGESTREL TABLET distributed to specific Family Dollar Stores 04/30/2022…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	AD PREV OINT ORIG 4 OZ distributed to specific Family Dollar Stores 04/30/2022 through…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	GOOD SENSE OMEPRAZOLE TABLET 14CT SKU 900055 PRILOSEC OTC TABLET 14 CT SKU914128…	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.	Ongoing
Class II	August 31, 2022	Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S.…	CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.	Midlab Incorporated	Terminated
Class II	August 31, 2022	Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl.…	CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.	Midlab Incorporated	Terminated
Class II	August 31, 2022	Divalproex Sodium Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx…	Failed dissolution specifications.	Amneal Pharmaceuticals of New York, LLC	Terminated
Class II	August 24, 2022	Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per…	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post…	Aire-Master of America Inc	Terminated
Class II	August 24, 2022	Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.)…	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post…	Aire-Master of America Inc	Terminated
Class II	August 24, 2022	Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC,…	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post…	Aire-Master of America Inc	Terminated
Class II	August 24, 2022	Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL…	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post…	Aire-Master of America Inc	Terminated
Class II	August 24, 2022	Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic…	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post…	Aire-Master of America Inc	Terminated
Class II	August 24, 2022	Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle,…	CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post…	Aire-Master of America Inc	Terminated
Class III	August 24, 2022	Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only,…	Subpotent Drug	Amerisource Health Services LLC	Terminated
Class II	August 24, 2022	PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL…	Defective Container: Product has incomplete induction seals.	Akorn, Inc	Ongoing
Class III	August 24, 2022	Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC…	Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.	Akron Pharma, Inc.	Terminated
Class III	August 24, 2022	Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b)…	Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.	Akron Pharma, Inc.	Terminated
Class II	August 24, 2022	PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag,…	CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.	Nephron Sterile Compounding Center LLC	Terminated
Class II	August 24, 2022	Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L,…	CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.	Nephron Sterile Compounding Center LLC	Terminated
Class II	August 24, 2022	fulvestrant Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx…	Failed Impurities/Degradation Specifications	Zydus Pharmaceuticals (USA) Inc	Terminated
Class I	August 24, 2022	M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made…	Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for…	MEDEK LLC	Terminated
Class II	August 24, 2022	PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose…	CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.	Nephron Sterile Compounding Center LLC	Terminated
Class II	August 24, 2022	PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged…	CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.	Nephron Sterile Compounding Center LLC	Terminated
Class II	August 24, 2022	Acetaminophen Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single…	Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate…	Baxter Healthcare Corporation	Terminated
Class II	August 24, 2022	Ketorolac Tromethamine Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose…	cGMP Deviations: deviations leading to potential cross-contamination.	Nephron Sc Inc	Terminated
Class II	August 24, 2022	rifampin Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin…	CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.	Lupin Pharmaceuticals Inc.	Terminated
Class III	August 24, 2022	ZYNRELEF Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose…	Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg…	HERON THERAPEUTICS, INC.	Terminated
Class II	August 17, 2022	A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ)…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx…	Lack of Assurance of Sterility	SterRx, LLC	Terminated
Class II	August 17, 2022	FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx…	Lack of Assurance of Sterility	SterRx, LLC	Terminated
Class II	August 17, 2022	Difluprednate Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles,…	Lack of Assurance of Sterility: Complaints received of defective container closure.	CIPLA	Terminated
Class II	August 17, 2022	Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops,…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	Naphcon A Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	Lorazepam Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured…	Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during…	Hikma Pharmaceuticals USA Inc.	Terminated
Class II	August 17, 2022	Lorazepam Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus,…	Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during…	Hikma Pharmaceuticals USA Inc.	Terminated
Class II	August 17, 2022	Lorazepam Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus,…	Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during…	Hikma Pharmaceuticals USA Inc.	Terminated
Class II	August 17, 2022	Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box),…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class III	August 17, 2022	Azacitidine Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By:…	Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below…	Teva Pharmaceuticals USA Inc	Terminated
Class II	August 17, 2022	Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b)…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for:…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	MiraLAX Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	PATADAY ONCE DAILY RELIEF Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%,…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only,…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	Prednisone Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma…	Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets	Strides Pharma Inc.	Terminated
Class II	August 17, 2022	Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only,…	Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and…	Glenmark Pharmaceuticals Inc., USA	Terminated
Class II	August 17, 2022	Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of…	CGMP Deviations: products were stored outside the drug label specifications.	Mckesson Medical-Surgical Inc. Corporate Office	Terminated
Class II	August 17, 2022	Telmisartan and Hydrochlorothiazide Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only,…	Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and…	Glenmark Pharmaceuticals Inc., USA	Terminated
Class II	August 17, 2022	Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX…	Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during…	Hikma Pharmaceuticals USA Inc.	Terminated
Class III	August 17, 2022	Lamotrigine Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE,…	Labeling: Label Error on Declared Strength	AVKARE Inc.	Terminated
Class I	August 10, 2022	SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton,…	Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.	Ultra Supplement LLC	Terminated
Class II	August 10, 2022	Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles,…	Failed Dissolution Specifications: below specification limits for dissolution.	Teva Pharmaceuticals USA Inc	Terminated
Class II	August 10, 2022	Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g tube (NDC…	Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity…	Tolmar, Inc.	Terminated
Class I	August 10, 2022	SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a…	Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.	Distributor RFR, LLC.	Terminated
Class III	August 10, 2022	Tacrolimus Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only,…	Defective Container: Tube split from side seam	Glenmark Pharmaceuticals Inc., USA	Ongoing
Class II	August 10, 2022	Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx…	Failed Dissolution Specifications: below specification limits for dissolution.	Teva Pharmaceuticals USA Inc	Terminated
Class I	August 3, 2022	Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461…	Subpotent and Superpotent Drug	Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy	Terminated
Class III	August 3, 2022	Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium…	Labeling: Missing label: the product tube was missing a label and contained a different formulation.	The Procter & Gamble Company	Completed
Class III	August 3, 2022	Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant…	Failed Dissolution Specifications	Eco Lips, Inc	Terminated
Class III	August 3, 2022	Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les…	Failed Dissolution Specifications	Eco Lips, Inc	Terminated
Class II	August 3, 2022	testosterone Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30…	Superpotent Drug: Out of specification assay result was obtained during stability testing.	Teva Pharmaceuticals USA Inc	Terminated
Class I	August 3, 2022	Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled…	Labeling: Missing label: Label missing from some prefilled pens.	Mylan Pharmaceuticals Inc	Terminated
Class II	August 3, 2022	Lansoprazole Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per…	FAILED DISSOLUTION SPECIFICATIONS	Dr. Reddy's Laboratories, Inc.	Terminated
Class II	August 3, 2022	Lansoprazole Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per…	FAILED DISSOLUTION SPECIFICATIONS	Dr. Reddy's Laboratories, Inc.	Terminated
Class II	August 3, 2022	Irbesartan Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant…	Failed dissolution specifications.	Jubilant Cadista Pharmaceuticals, Inc.	Terminated
Class II	August 3, 2022	Irbesartan Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant…	Failed Dissolution Specifications	Jubilant Cadista Pharmaceuticals, Inc.	Terminated
Class II	August 3, 2022	Divalproex Sodium Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed…	Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.	SUN PHARMACEUTICAL INDUSTRIES INC	Terminated
Class I	August 3, 2022	propofol Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop…	Presence of particulate matter: particulate identified as a beetle.	Pfizer Inc.	Terminated
Class II	July 27, 2022	Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.	Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.	Loud Muscle Science	Terminated
Class I	July 27, 2022	Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.	Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA…	Loud Muscle Science	Terminated
Class I	July 27, 2022	Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.	Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA…	Loud Muscle Science	Terminated
Class II	July 27, 2022	Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC…	Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.	Loud Muscle Science	Terminated
Class I	July 27, 2022	Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en…	Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.	Amazon.com, Inc.	Terminated
Class I	July 27, 2022	Artri King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en…	Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.	Amazon.com, Inc.	Terminated
Class I	July 27, 2022	Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC…	Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA…	Loud Muscle Science	Terminated
Class I	July 27, 2022	Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30…	Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.	Amazon.com, Inc.	Terminated
Class II	July 27, 2022	Difluprednate Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd.,…	Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes…	CIPLA	Terminated
Class II	July 27, 2022	Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.	Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.	Loud Muscle Science	Terminated
Class II	July 27, 2022	8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packaged in 5 x 4…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*)…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Filled…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag,…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL)…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 mL…	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC	Terminated
Class II	July 27, 2022	Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC…	Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.	Apotex Corp.	Terminated
Class III	July 27, 2022	Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx…	Failed Tablet/Capsule Specification : Capsule breakage	Glenmark Pharmaceuticals Inc., USA	Ongoing
Class II	July 27, 2022	Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a)…	Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.	Vi-Jon, LLC	Terminated
Class II	July 20, 2022	Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial,…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature,…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate,…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, Room…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial,…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate,…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature,…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b)…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Vitamin D3 50,000IU/mL, 10mL-vial, Room Temperature, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature, Tailor…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class II	July 20, 2022	Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperature, Tailor…	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding	Ongoing
Class I	July 20, 2022	Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only,…	Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30…	Bryant Ranch Prepack, Inc.	Terminated
Class I	July 20, 2022	Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only,…	Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30…	Bryant Ranch Prepack, Inc.	Terminated
Class II	July 20, 2022	Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg…	Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.	Jubilant Draximage Inc	Terminated
Class I	July 20, 2022	Arti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por:…	Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and…	Latin Foods Market	Terminated
Class II	July 20, 2022	Testosterone Cypionate Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial,…	cGMP - Water leakage	SUN PHARMACEUTICAL INDUSTRIES INC	Terminated
Class II	July 20, 2022	Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distributed by: CVS…	Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and…	Vi-Jon, LLC	Terminated
Class I	July 13, 2022	CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL…	Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter…	Vi-Jon, LLC	Terminated
Class II	July 13, 2022	Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village…	Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection	Wedgewood Village Pharmacy, LLC	Terminated
Class II	July 13, 2022	Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405…	Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection	Wedgewood Village Pharmacy, LLC	Terminated
Class II	July 13, 2022	Eszopiclone Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for:…	Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.	Macleods Pharma Usa Inc	Terminated
Class II	July 13, 2022	Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1, Wedgewood…	Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection	Wedgewood Village Pharmacy, LLC	Terminated
Class II	July 13, 2022	Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405…	Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection	Wedgewood Village Pharmacy, LLC	Terminated
Class II	July 13, 2022	Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC,…	Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection	Wedgewood Village Pharmacy, LLC	Terminated
Class II	July 13, 2022	Doxycycline (as Calcium) (equivalent to 50mg/5mL), 10 mg/ml, 60 ml suspension bottles,…	Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection	Wedgewood Village Pharmacy, LLC	Terminated
Class III	July 13, 2022	Mometasone Furoate Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC…	Defective Container	Glenmark Pharmaceuticals Inc., USA	Terminated
Class II	July 13, 2022	Testosterone Cypionate Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial,…	CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.	SUN PHARMACEUTICAL INDUSTRIES INC	Terminated
Class II	July 13, 2022	Enalapril Maleate Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro…	CGMP Deviations	Golden State Medical Supply Inc.	Ongoing
Class II	July 13, 2022	Enalapril Maleate Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro…	CGMP Deviations	Golden State Medical Supply Inc.	Ongoing
Class II	July 13, 2022	Enalapril Maleate Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro…	CGMP Deviations	Golden State Medical Supply Inc.	Ongoing
Class II	July 13, 2022	Enalapril Maleate Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by…	CGMP Deviations	Golden State Medical Supply Inc.	Ongoing
Class I	July 6, 2022	Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ (10 mL) tubes, UPC Code…	Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of…	Buzzagogo, LLC	Terminated
Class II	July 6, 2022	Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.)…	Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.	Akorn, Inc.	Terminated
Class II	July 6, 2022	Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for:…	CGMP Deviations	Glenmark Pharmaceuticals Inc., USA	Terminated