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Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 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 8 FDA drug recalls.

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DateProductReasonClassFirm
Feb 24, 2025 Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35... Chemical Contamination: Presence of benzene. Class II Denison Pharmaceuticals, LLC
Sep 25, 2024 Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin,... Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal subs... Class III Denison Pharmaceuticals, LLC
Sep 25, 2024 Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin... Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal subs... Class III Denison Pharmaceuticals, LLC
May 28, 2024 Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz.... cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel e... Class II Denison Pharmaceuticals, LLC
May 3, 2023 Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaife... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Denison Pharmaceuticals, LLC
May 3, 2023 Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottl... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Denison Pharmaceuticals, LLC
May 3, 2023 Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Do... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Denison Pharmaceuticals, LLC
May 3, 2023 Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL ... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Denison Pharmaceuticals, 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.