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Browse Drug Recalls

14 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14 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 14 FDA drug recalls.

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DateProductReasonClassFirm
Oct 24, 2025 Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... Failed stability specifications: Out of specification for hardness test Class II Cipla USA, Inc.
Oct 24, 2025 Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack ... Failed stability specifications: Out of specification for hardness test Class II Cipla USA, Inc.
Nov 17, 2023 Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx O... Defective Container: powder may leak out of the pouch Class I InvaGen Pharmaceuticals, Inc.
May 14, 2020 Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: ... Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-ter... Class III InvaGen Pharmaceuticals, Inc.
Jun 12, 2019 Testosterone Topical Solution 30mg of testosterone per pump actuation * each ... Defective Container; actuator may improperly function and affect dose delivery. Class III InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial,... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramu... Presence of Particulate Matter. Class II InvaGen Pharmaceuticals, Inc.
Mar 22, 2019 Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramu... Presence of Particulate Matter. Class II InvaGen 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 6, 2018 Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottl... Failed impurities/ degradation specifications: Out-of-specification results were observed in the ... Class III InvaGen Pharmaceuticals, Inc.
Mar 15, 2018 buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles,... Failed Dissolution Specifications; during stability testing Class III InvaGen Pharmaceuticals, Inc.
Mar 15, 2018 buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC ... Failed Dissolution Specifications; during stability testing Class III InvaGen Pharmaceuticals, Inc.
Mar 5, 2018 Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd.... Failed impurities/degradation specifications: Failure to water content and impurity Class III InvaGen Pharmaceuticals, Inc.
Apr 22, 2013 Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufact... Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine ... Class II Legacy Pharmaceutical Packaging 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.