Browse Drug Recalls

557 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 557 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 557 FDA drug recalls in 2024.

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DateProductReasonClassFirm
Jan 8, 2024 Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactu... Failed Dissolution Specifications Class II Teva Pharmaceuticals USA, Inc
Jan 5, 2024 Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lup... Subpotent Drug and Failed Impurities/Degradation Specifications Class II Lupin Pharmaceuticals Inc.
Jan 5, 2024 Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lu... Subpotent Drug and Failed Impurities/Degradation Specifications Class II Lupin Pharmaceuticals Inc.
Jan 4, 2024 Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill v... Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol Class II Glenmark Pharmaceuticals Inc., USA
Jan 4, 2024 Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle,... Labeling: Label Mix-up Class I Azurity Pharmaceuticals, Inc.
Jan 3, 2024 Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured f... Failed Impurities/Degradation Specifications Class II Lupin Pharmaceuticals Inc.
Jan 2, 2024 Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's ... Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets. Class II 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.