Browse Drug Recalls

1,720 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,720 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 1,720 FDA drug recalls, Class III.

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DateProductReasonClassFirm
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.
Nov 7, 2025 Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dos... Defective Container - A defect in the side-seal which allows leakage of product. Class III Teva Pharmaceuticals USA, Inc
Oct 20, 2025 Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emu... Subpotent Drug Class III Imprimis NJOF, LLC
Oct 10, 2025 Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips wit... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Oct 10, 2025 Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx on... Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the s... Class III Alembic Pharmaceuticals Limited
Oct 10, 2025 Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips w... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Oct 10, 2025 Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips ... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Oct 10, 2025 Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips w... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Oct 9, 2025 FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 5... Labeling: Incorrect or Missing Lot and/or Exp Date Class III STAQ Pharma, Inc.
Oct 9, 2025 Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50... Labeling: Incorrect or Missing Lot and/or Exp Date Class III STAQ Pharma, Inc.
Oct 9, 2025 Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syri... Labeling: Incorrect or Missing Lot and/or Exp Date Class III STAQ Pharma, Inc.
Sep 12, 2025 Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured... Tablet/Capsules Imprinted with Wrong ID Class III JB Chemicals and Pharmaceuticals Ltd
Sep 12, 2025 Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 Labeling: Not Elsewhere Classified Class III Letco Medical LLC
Sep 12, 2025 Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured... Tablet/Capsules Imprinted with Wrong ID Class III JB Chemicals and Pharmaceuticals Ltd
Sep 5, 2025 Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips wit... Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class III Endo USA, Inc.
Aug 28, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Failed Impurities/Degradation Specifications: Class III Granules Pharmaceuticals Inc.
Aug 28, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Failed Impurities/Degradation Specifications: Class III Granules Pharmaceuticals Inc.
Aug 28, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Failed Impurities/Degradation Specifications: Class III Granules Pharmaceuticals Inc.
Aug 28, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Failed Impurities/Degradation Specifications: Class III Granules Pharmaceuticals Inc.
Aug 28, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Failed Impurities/Degradation Specifications: Class III Granules Pharmaceuticals Inc.
Aug 25, 2025 Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By T... Cross Contamination with Other Products. Class III Consumer Product Partners, LLC
Aug 25, 2025 TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distribu... Cross Contamination with Other Products. Class III Consumer Product Partners, LLC
Aug 19, 2025 READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile,... Subpotent drug Class III Medline Industries, LP
Aug 5, 2025 Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIEL... Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/W... Class III Haleon US Holdings LLC
Jul 24, 2025 Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET C... Failed Stability Specifications: Out of specification results was observed in Induction Port duri... Class III Cipla USA, Inc.
Jul 9, 2025 Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 Subpotent Drug Class III Boothwyn Pharmacy LLC
Jul 9, 2025 Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution... Sub-Potent Drug: Subpotent assay results during stability testing. Class III Imprimis NJOF, LLC
Jun 26, 2025 Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... Failed Impurity/Degradation Specifications Class III AvKARE
Jun 26, 2025 Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... Failed Impurity/Degradation Specifications Class III AvKARE
Jun 16, 2025 Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded p... Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot n... Class III Qualgen, LLC
Jun 11, 2025 Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Phar... Failed Impurities/Degradation Specifications. Class III Orient Pharma Co., Ltd. Yunlin Plant
Jun 11, 2025 Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for:... Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. Class III Macleods Pharmaceuticals Ltd
Jun 11, 2025 Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Phar... Failed Impurities/Degradation Specifications. Class III Orient Pharma Co., Ltd. Yunlin Plant
May 29, 2025 Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, M... Presence of a foreign substance: black hair found embedded in tablet. Class III Macleods Pharmaceuticals Ltd
May 19, 2025 Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manuf... Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances t... Class III Glenmark Pharmaceuticals Inc., USA
Apr 15, 2025 HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette,... Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was ... Class III OurPharma LLC
Mar 4, 2025 Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, ... Cross Contamination Class III SUN PHARMACEUTICAL INDUSTRIES INC
Mar 4, 2025 Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Un... Failed Dissolution Specifications: Out of specification results obtained during routine stability... Class III The Harvard Drug Group LLC dba Major Pharmaceut...
Mar 4, 2025 Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, N... Cross Contamination Class III SUN PHARMACEUTICAL INDUSTRIES INC
Feb 24, 2025 Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Sol... Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product s... Class III Imprimis NJOF, LLC
Feb 24, 2025 Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured... Presence of foreign tablets/capsules Class III Kowa Pharmaceuticals America

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.