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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
Jul 10, 2024 Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per ... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg ins... Class I Endo Pharmaceuticals, Inc.
Mar 2, 2023 Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL correspon... Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification result... Class II Endo Pharmaceuticals, Inc.
Sep 17, 2018 robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, ... Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly... Class I Endo Pharmaceuticals, Inc.
Feb 22, 2017 Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only,... Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance.... Class II Endo Pharmaceuticals, Inc.
May 7, 2012 Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count t... Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablet... Class III Endo Pharmaceuticals, 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.