Browse Drug Recalls

1,152 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,152 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 1,152 FDA drug recalls in 2021.

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DateProductReasonClassFirm
Mar 22, 2021 Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL a... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Pre... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose ... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefill... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Pre... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dos... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 22, 2021 TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Pre... Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... Class I Novo Nordisk Inc
Mar 19, 2021 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled stora... Class I CareFusion 213, LLC
Mar 19, 2021 Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, M... Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological ... Class II X-Gen Pharmaceuticals Inc.
Mar 19, 2021 Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Bli... Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed ... Class III Asclemed USA Inc. dba Enovachem Pharmaceuticals
Mar 19, 2021 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ... Class I CareFusion 213, LLC
Mar 19, 2021 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel... Class II CareFusion 213, LLC
Mar 19, 2021 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ... Class I CareFusion 213, LLC
Mar 19, 2021 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ... Class II CareFusion 213, LLC
Mar 19, 2021 Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only,... Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown i... Class II Golden State Medical Supply Inc.
Mar 19, 2021 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ... Class II CareFusion 213, LLC
Mar 19, 2021 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled stor... Class I CareFusion 213, LLC
Mar 19, 2021 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel... Class II CareFusion 213, LLC
Mar 18, 2021 Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.... An error occurred where the product was manufactured with Potassium Chloride instead of Potassium... Class III Washington Homeopathic Products, Inc.
Mar 18, 2021 LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by... An error occurred where the product was manufactured with Potassium Chloride instead of Potassium... Class III Washington Homeopathic Products, Inc.
Mar 18, 2021 Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for:... An error occurred where the product was manufactured with Potassium Chloride instead of Potassium... Class III Washington Homeopathic Products, Inc.
Mar 17, 2021 Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: A... Labeling: Label-mixup Class I Alembic Pharmaceuticals Limited
Mar 15, 2021 Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containi... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactru... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAP... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-... 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 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 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 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 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 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 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 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 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 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 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 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 Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg ... 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.