Browse Drug Recalls

278 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 278 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 278 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 9, 2021 Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe ... Temperature Abuse Class III Cardinal Health Inc.
Feb 3, 2020 Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reduc... Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement... Class II Contract Pharmacal Corporation
Sep 6, 2019 Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For... Temperature Abuse; Product stored and shipped outside of labeled storage requirements. Class II Cardinal Health dba Specialty Pharmaceutical Se...
Sep 13, 2017 Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in ... Failed Impurities/Degradation Specifications. Class III Vi-Jon, Inc.
Sep 28, 2015 Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter un... Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester Class III Perrigo Company PLC
Jul 28, 2015 Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets... Superpotent Drug: Out Of Specification (OOS) result for Assay. Class III Ohm Laboratories, Inc.
Nov 1, 2013 Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) b... Defective Delivery System: There is a remote potential that cartons of product could be co-packag... Class II L. Perrigo Co.
Nov 1, 2013 Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) ... Defective Delivery System: There is a remote potential that cartons of product could be co-packag... Class II L. Perrigo Co.
Oct 2, 2013 Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blist... Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mE... Class III Cardinal Health
Sep 4, 2012 Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Su... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, 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.