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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Feb 12, 2024 CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1... CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was... Class II MCKESSON CORPORATION
Feb 2, 2024 Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This pac... Subpotent Drug: Out of specification for assay Class II Bausch Health Companies, Inc.
Jun 8, 2021 Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Ocean... Failed Impurities/Degradation Specifications Class III Bausch Health Companies, Inc.
Jun 8, 2021 Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufacture... Failed Impurities/Degradation Specifications Class III Bausch Health Companies, Inc.
Jan 7, 2021 Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured ... Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t... Class III Bausch Health Companies, Inc.
Jan 7, 2021 Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceansi... Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t... Class III Bausch Health Companies, Inc.
Jul 13, 2020 Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for... SUBPOTENT DRUG Class II Bausch Health Companies, 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.