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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Date	Product	Reason	Class	Firm
Feb 18, 2021	Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For In...	Crystallization: customer complaints for crystallization in finished product.	Class I	Zydus Pharmaceuticals (USA) Inc
Feb 17, 2021	Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-3...	Failed Dissolution Specifications	Class II	Dr. Reddy's Laboratories, Inc.
Feb 17, 2021	Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solut...	Lack of Assurance of Sterility	Class II	The General Hospital Corporation
Feb 17, 2021	Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Pres...	Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rath...	Class III	Edge Pharma, LLC
Feb 15, 2021	Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distribute...	Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and ...	Class I	Adams.Secret.co
Feb 15, 2021	Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials,...	Chemical contamination; Unknown brown residue adhering to the inside of one vial.	Class II	Teva Pharmaceuticals USA
Feb 15, 2021	Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distribute...	Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and ...	Class I	Adams.Secret.co
Feb 10, 2021	Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC ...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), pa...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL,...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-D...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-do...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL),...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL)...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Te...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), ...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 5, 2021	Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distribute...	Failed Impurity/Degradation Specifications	Class III	SUN PHARMACEUTICAL INDUSTRIES INC
Feb 4, 2021	Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: ...	Failed Dissolution Specifications	Class II	Wilshire Pharmaceuticals Inc
Feb 4, 2021	Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wi...	Failed Dissolution Specifications	Class II	Wilshire Pharmaceuticals Inc
Feb 2, 2021	Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automati...	Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 12...	Class I	Apotex Corp.
Feb 2, 2021	Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 g...	Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.	Class III	Teligent Pharma, Inc.
Feb 2, 2021	Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 gr...	Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.	Class III	Teligent Pharma, Inc.
Feb 2, 2021	Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Aut...	Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 m...	Class I	Apotex Corp.
Feb 2, 2021	Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 gr...	Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.	Class III	Teligent Pharma, Inc.
Feb 1, 2021	Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed...	Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled a...	Class II	Kimberly-Clark Corporation
Jan 29, 2021	Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manuf...	Failed Dissolution Specifications	Class III	Akebia Therapeutics dba Keryx Biopharmaceutials...
Jan 28, 2021	Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose V...	Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled fo...	Class III	Accord Healthcare, Inc.
Jan 27, 2021	Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Ma...	Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolact...	Class II	Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Jan 27, 2021	Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 636...	Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolact...	Class I	Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Jan 27, 2021	Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dos...	Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain t...	Class I	Meitheal Pharmaceuticals Inc
Jan 25, 2021	Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets pe...	CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ...	Class II	Nostrum Laboratories Inc
Jan 22, 2021	Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx O...	CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si...	Class II	Ascend Laboratories LLC
Jan 22, 2021	Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx On...	CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si...	Class II	Ascend Laboratories LLC
Jan 21, 2021	Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic o...	Superpotent Drug. Lidocaine higher concentration than listed	Class II	Stanley Specialty Pharmacy Compounding and Well...
Jan 21, 2021	Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume afte...	Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impu...	Class III	Lupin Pharmaceuticals Inc.
Jan 20, 2021	Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Au...	Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a...	Class II	Aurobindo Pharma USA Inc.
Jan 15, 2021	Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by C...	Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ...	Class I	Calvin Scott & Company, Inc.
Jan 15, 2021	Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distribute...	Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ...	Class III	Calvin Scott & Company, Inc.
Jan 11, 2021	Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONL...	Incorrect Labeling: Incorrect lot number on secondary packaging	Class III	SUN PHARMACEUTICAL INDUSTRIES INC
Jan 8, 2021	Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmac...	CGMP deviations.	Class II	Taro Pharmaceuticals U.S.A., Inc.
Jan 7, 2021	Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceansi...	Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t...	Class III	Bausch Health Companies, Inc.
Jan 7, 2021	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per cart...	Failed Dissolution Specifications	Class II	American Health Packaging
Jan 7, 2021	Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured ...	Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t...	Class III	Bausch Health Companies, Inc.
Jan 6, 2021	Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ F...	Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly place...	Class II	DLC Laboratories, 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.