Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Mar 15, 2021 Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufa... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: T... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 7583... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manuf... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Gr... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topi... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 6... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt.... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: P... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NO... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Onl... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUS... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inh... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% a... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Wee... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Ma... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott La... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Pre... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 5... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx on... Failed Impurities/Degradation Specifications Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 15, 2021 Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epi... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containi... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inh... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.