Browse Drug Recalls

1,710 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,710 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 1,710 FDA drug recalls, Class III.

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DateProductReasonClassFirm
Jul 16, 2026 Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further p... Failed impurity/degradation specification: an OOS result observed in Related substance test analy... Class III Ascend Laboratories, LLC
Jul 16, 2026 Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient sp... Incorrect Product Formulation Class III Central Admixture Pharmacy Services Inc
Jul 16, 2026 Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further pa... Failed impurity/degradation specification: an OOS result observed in Related substance test analy... Class III Ascend Laboratories, LLC
Jul 16, 2026 Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further pac... Failed impurity/degradation specification: an OOS result observed in Related substance test analy... Class III Ascend Laboratories, LLC
Jul 15, 2026 Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dos... Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan Class III Asclemed USA Inc.
Jul 6, 2026 Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only... Failed Dissolution Specifications Class III Supernus Pharmaceuticals, Inc.
Jun 30, 2026 Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manuf... Failed Impurities/Degradation Specifications: OOS result was observed during the related substanc... Class III Ascend Laboratories, LLC
Jun 30, 2026 Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manuf... Failed Impurities/Degradation Specifications: OOS result was observed during the related substanc... Class III Ascend Laboratories, LLC
Jun 3, 2026 Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured ... Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetac... Class III Amneal Pharmaceuticals, LLC
Jun 2, 2026 hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx... Presence of foreign substance Class III ANI Pharmaceuticals, Inc.
Jun 1, 2026 Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets pe... Failed Impurities/Degradation Specifications Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jun 1, 2026 Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bo... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Sandoz Inc
May 18, 2026 Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose ... Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan Class III Eugia US LLC
May 18, 2026 PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Ste... Failed Stability Specifications Class III AbbVie Inc.
May 14, 2026 Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius... Failed Impurities/Degradations Specifications Class III Fresenius Kabi USA, LLC
May 14, 2026 Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distribu... Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, ex... Class III AVEVA Drug Delivery Systems, Inc.
May 4, 2026 Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials,... Failed Impurities/Degradation Specifications Class III Sagent Pharmaceuticals
May 1, 2026 Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per c... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Amerisource Health Services LLC
May 1, 2026 Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per ca... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Amerisource Health Services LLC
Apr 27, 2026 Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: L... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Golden State Medical Supply Inc.
Apr 27, 2026 Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lan... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Golden State Medical Supply Inc.
Apr 24, 2026 Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lann... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Lannett Company Inc.
Apr 16, 2026 Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, Fo... Labeling: Missing Label Class III American Regent, Inc.
Apr 14, 2026 Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufac... Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is ... Class III Premier Dental Products Co
Apr 13, 2026 busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufa... Subpotent drug Class III Unichem Pharmaceuticals USA Inc.
Apr 7, 2026 Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride... Failed PH Specifications Class III Water-Jel Technologies, LLC
Mar 31, 2026 Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmace... Subpotent drug Class III Avantor Performance Materials LLC
Mar 18, 2026 Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz n... Subpotent Drug Class III Island Kinetics, Inc. d.b.a. CoValence Laborato...
Mar 18, 2026 Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per j... Subpotent Drug Class III Island Kinetics, Inc. d.b.a. CoValence Laborato...
Mar 18, 2026 Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo... Subpotent Drug Class III Island Kinetics, Inc. d.b.a. CoValence Laborato...
Feb 19, 2026 Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 e... Failed Tablet/Capsule Specifications Class III Radnostix
Feb 18, 2026 Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufac... Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... Class III Cipla USA, Inc.
Feb 18, 2026 Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufac... Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... Class III Cipla USA, Inc.
Feb 12, 2026 Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1... Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 ... Class III Slate Run Pharmaceuticals
Feb 3, 2026 Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactur... Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin... Class III Annora Pharma Private Limited
Jan 21, 2026 Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed b... Tablets/Capsules Imprinted with Wrong ID Class III Unichem Pharmaceuticals USA Inc.
Dec 30, 2025 Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, R... Failed Impurities/Degradation Specifications: Out of specification result was obtained for the kn... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Dec 26, 2025 parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net ... Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and ex... Class III Haleon US Holdings LLC
Dec 22, 2025 Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: D... Failed PH Specifications Class III Cipla USA, Inc.
Dec 19, 2025 traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufact... Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on ... Class III Zydus Pharmaceuticals (USA) Inc
Dec 16, 2025 Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, M... Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the s... Class III Alembic Pharmaceuticals Limited
Dec 15, 2025 Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactur... Failed Impurities/Degradation Specifications Class III NOVADOZ PHARMACEUTICALS LLC
Nov 26, 2025 Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applica... Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. Class III SUN PHARMACEUTICAL INDUSTRIES INC
Nov 26, 2025 Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-... Subpotent product:out of specification assay results observed during long term stability testing. Class III SOMERSET THERAPEUTICS LLC
Nov 26, 2025 Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single... Subpotent product:out of specification assay results observed during long term stability testing. Class III SOMERSET THERAPEUTICS LLC
Nov 26, 2025 Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, F... Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle ... Class III Winder Laboratories, LLC
Nov 26, 2025 Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Mult... Subpotent product:out of specification assay results observed during long term stability testing. Class III SOMERSET THERAPEUTICS LLC
Nov 21, 2025 Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, pac... Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ... Class III Glenmark Pharmaceuticals Inc., USA
Nov 18, 2025 Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Phar... Cross Contamination with Other Products Class III Glenmark Pharmaceuticals Inc., USA
Nov 11, 2025 Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Labor... Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lo... Class III Dr. Reddy's 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.