Browse Drug Recalls

1,680 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,680 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 1,680 FDA drug recalls — Class III.

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DateProductReasonClassFirm
Feb 13, 2019 Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, ... Failed Degradation/Impurities Specifications: Out of specification related substance results duri... Class III Perrigo New York, Inc.
Feb 13, 2019 Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and ... CGMP Deviations: Finished product made with lovastatin drug substance that was out of specificati... Class III Lupin Pharmaceuticals Inc.
Feb 13, 2019 Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count ... Failed Impurities/Degradation Specifications: High out of specification results obtained during r... Class III Mylan Pharmaceuticals Inc.
Feb 7, 2019 Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Labo... Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error. Class III ACP Nimble Buyer, Inc.
Feb 6, 2019 Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Inje... Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... Class III Advanced Pharma Inc.
Feb 6, 2019 Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... Class III Advanced Pharma Inc.
Feb 6, 2019 Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented ... Class III Advanced Pharma Inc.
Feb 6, 2019 Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottl... Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets. Class III Dr. Reddy's Laboratories, Inc.
Feb 1, 2019 Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Man... Failed Impurities/Degradation Specifications: Out of specification test results in related substa... Class III Lupin Pharmaceuticals Inc.
Jan 30, 2019 Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured fo... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for dissolution when measuri... Class III Valeant Pharmaceuticals North America LLC
Jan 28, 2019 Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02)... Failed Impurities/Degradation Specifications: OOS results observed in any other individual impuri... Class III Lupin Pharmaceuticals Inc.
Jan 25, 2019 Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) an... Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month ... Class III Akorn Inc
Jan 11, 2019 Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufact... Defective Container; complaints of leakage. Class III Oxalis Labs
Dec 26, 2018 LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC... Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel i... Class III Sun Pharmaceutical Industries, Inc.
Dec 20, 2018 COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol ... Failed Stability Specifications: out of specification results for opalescence at 7 month stabilit... Class III Akorn Inc
Dec 20, 2018 Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and... Failed Dissolution Specifications Class III Amerigen Pharmaceuticals Inc.
Dec 20, 2018 Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, ... Failed Dissolution Specifications Class III Amerigen Pharmaceuticals Inc.
Dec 10, 2018 Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, ... Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. Class III CBI Laboratories, Inc.
Dec 10, 2018 Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenz... Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. Class III CBI Laboratories, Inc.
Dec 7, 2018 Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Pa... Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained dur... Class III Sun Pharmaceutical Industries, Inc.
Nov 30, 2018 Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bo... Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets f... Class III Aurobindo Pharma USA Inc.
Nov 30, 2018 NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged... Failed Impurities/Degradation Specifications:Out of specification for impurities. Class III VistaPharm, Inc.
Nov 27, 2018 Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufa... Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule... Class III Glenmark Pharmaceuticals Inc., USA
Nov 21, 2018 Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 m... Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium C... Class III QuVa Pharma, Inc.
Nov 9, 2018 Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Un... Cross contamination with other products: This sub-recall is being initiated in support of the rec... Class III AMERICAN HEALTH PACKAGING
Nov 8, 2018 ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use v... Labeling: Missing label; potential for missing primary container label on the vial. Class III Eli Lilly & Co
Nov 7, 2018 Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60... Cross contamination with other products: Product is being recalled due to the potential presence ... Class III RemedyRepack Inc.
Nov 6, 2018 Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Di... Failed Stability Specifications: Out-of-Specification results obtained for particle size distribu... Class III Breckenridge Pharmaceutical, Inc.
Nov 6, 2018 AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by:... Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month ... Class III Takeda Development Center Americas, Inc.
Nov 2, 2018 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in ... Cross Contamination with Other Products Class III Sandoz Inc
Nov 2, 2018 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bo... Cross Contamination with Other Products Class III Sandoz Inc
Nov 1, 2018 Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe... Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May... Class III Bound Tree Medical, LLC
Oct 29, 2018 Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 ple... Failed Impurities/Degradation Specifications; out of specification results observed for other ind... Class III Akorn, Inc.
Oct 26, 2018 Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifes... Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability... Class III RemedyRepack Inc.
Oct 18, 2018 Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bott... Presence of precipitate Class III Promise Pharmacy LLC
Oct 15, 2018 Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile si... Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the imp... Class III Baxter Healthcare Corporation
Oct 9, 2018 Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactur... Defective Container: Repetitive complaints received indicating pump not working. Class III Lupin Pharmaceuticals Inc.
Oct 5, 2018 Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90... Container packaging defect. Class III Orexigen Therapeutics, Inc.
Oct 5, 2018 Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05)... Failed dissolution specifications: Out-of-Specification dissolution results obtained during stabi... Class III Amerigen Pharmaceuticals Inc.
Oct 3, 2018 Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactu... Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 mo... Class III InvaGen Pharmaceuticals, Inc.
Sep 25, 2018 Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pi... Labeling Not Elsewhere Classified: Misbranding. Class III Right Value Drug Stores, Inc.
Sep 25, 2018 Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw ... Labeling Not Elsewhere Classified: Misbranding. Class III Right Value Drug Stores, Inc.
Sep 25, 2018 Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 360... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation
Sep 25, 2018 Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw ... Labeling Not Elsewhere Classified: Misbranding. Class III Right Value Drug Stores, Inc.
Sep 25, 2018 Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top p... Labeling Not Elsewhere Classified: Misbranding. Class III Right Value Drug Stores, Inc.
Sep 18, 2018 Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 m... Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging com... Class III Xiromed LLC

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.