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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
Oct 10, 2025 Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottl... Failed Dissolution Specifications Class II Lannett Company Inc.
Aug 19, 2025 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amph... Class II Lannett Company Inc.
Aug 11, 2025 Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Dist... Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained... Class II Lannett Company Inc.
Oct 25, 2024 Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only... Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified... Class II Lannett Company Inc.
Nov 9, 2022 Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1... Failed Impurity/Degradation Specifications Class III Lannett Company Inc.
Nov 9, 2022 Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [... Failed Impurity/Degradation Specifications Class III Lannett Company Inc.
Feb 21, 2019 Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only... Failed Dissolution Specifications Class III Lannett Company 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.