Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Sep 30, 2021 Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, N... Chemical contamination; presence of benzene Class I Beiersdorf Inc
Sep 30, 2021 Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, N... cGMP Deviations Class II Beiersdorf Inc
Sep 30, 2021 Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... Chemical contamination; presence of benzene Class I Beiersdorf Inc
Sep 30, 2021 Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 1... Chemical contamination; presence of benzene Class I Beiersdorf Inc
Sep 30, 2021 Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... Chemical contamination; presence of benzene Class I Beiersdorf Inc
Sep 30, 2021 Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... cGMP Deviations Class II Beiersdorf Inc
Sep 30, 2021 Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... cGMP Deviations Class II Beiersdorf Inc
Sep 30, 2021 Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, N... Chemical contamination; presence of benzene Class I Beiersdorf Inc
Sep 28, 2021 Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC... Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... Class III Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sep 28, 2021 Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC:... Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... Class III Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sep 28, 2021 The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL O... Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Men... Class II Revive Personal Products Company
Sep 27, 2021 Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 S... Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of steril... Class II AMIVAS (US), LLC
Sep 27, 2021 Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets... Failed Dissolution Specifications Class II Strides Pharma Inc.
Sep 24, 2021 Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per ... SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. The... Class I Eli Lilly & Company
Sep 23, 2021 Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Man... Finished product specification did not meet USP specifications. Class II Monarch PCM, LLC
Sep 22, 2021 AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg... Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class II Teva Pharmaceuticals USA
Sep 22, 2021 AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg... Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class II Teva Pharmaceuticals USA
Sep 22, 2021 Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial... Lack of Assurance of Sterility Class II New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Sep 22, 2021 AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) ... Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class II Teva Pharmaceuticals USA
Sep 22, 2021 AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg... Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class II Teva Pharmaceuticals USA
Sep 22, 2021 AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg... Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class II Teva Pharmaceuticals USA
Sep 22, 2021 Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx O... Lack of Assurance of Sterility Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Sep 21, 2021 Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bot... Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained duri... Class II SigmaPharm Laboratories LLC
Sep 21, 2021 Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chl... CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or ... Class II Sanitor Corporation
Sep 17, 2021 ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, I... Lack of sterility assurance. Class II IntegraDose Compounding Services LLC
Sep 17, 2021 GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each ... Failed Dissolution Specifications: results were above specification. Class II American Health Packaging
Sep 17, 2021 Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only,... Defective container: Cracked vials leading to lack of sterility assurance Class II Fresenius Kabi USA LLC
Sep 17, 2021 ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Prod... Lack of sterility assurance. Class II IntegraDose Compounding Services LLC
Sep 15, 2021 Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per ... CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... Class II American Health Packaging
Sep 14, 2021 Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Di... CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory. Class II Direct Rx
Sep 13, 2021 Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for:... Failed Impurities/Degradation Specifications; out of specification for Related Compound Class III Viatris
Sep 10, 2021 Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufac... Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the... Class II Piramal Critical Care, Inc.
Sep 9, 2021 Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Di... Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrec... Class II Vi-Jon, Inc.
Sep 9, 2021 Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distribu... Presence of Foreign Substance: Product complaints received for the presence of metal wire in one ... Class II Aurobindo Pharma USA Inc.
Sep 9, 2021 Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only... Microbial contamination of non-sterile products: Firm's testing found lots to exceed specificatio... Class I Jacobus Pharmaceutical Company Inc.
Sep 8, 2021 TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 3... Lack of Assurance of Sterility Class II Akorn, Inc.
Sep 3, 2021 Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP... CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... Class II Morton Grove Pharmaceuticals, Inc.
Sep 3, 2021 Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/... CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... Class II Morton Grove Pharmaceuticals, Inc.
Sep 3, 2021 AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible co... Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous ... Class I ICU Medical Inc
Sep 3, 2021 Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, ... Failed Impurities/Degradation Specifications Class III Meitheal Pharmaceuticals Inc
Sep 3, 2021 Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, M... CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... Class II Morton Grove Pharmaceuticals, Inc.
Sep 2, 2021 CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flav... Subpotent Drug Class III New Vision Pharmaceuticals LLC
Sep 2, 2021 Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each... Subpotent Drug Class III New Vision Pharmaceuticals LLC
Sep 2, 2021 Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed ... Labeling: Incorrect Instructions Class II RISING PHARMACEUTICALS
Sep 1, 2021 Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC... Subpotency: one product for active ingredient assay and another one for preservative assay Class III Monarch PCM, LLC
Sep 1, 2021 Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, R... Subpotency: one product for active ingredient assay and another one for preservative assay Class III Monarch PCM, LLC
Aug 27, 2021 Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Conta... Lack of Assurance of Sterility Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactu... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufa... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmac... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA

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.