Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
Jul 22, 2026 Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL -... Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. Class II MICRO LABS USA INC
Feb 9, 2024 Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured b... Failed Stability Specifications: Out of specification for blend uniformity. Class II Micro Labs Limited
Dec 4, 2014 Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: M... Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class III Micro Labs Usa, Inc ...
Dec 4, 2014 Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-c... Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class III Micro Labs Usa, Inc ...
Dec 4, 2014 Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: M... Failed Impurities/Degradation Specifications: Product failed a known impurity specification. Class III Micro Labs Usa, Inc ...
Aug 19, 2014 Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: ... Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy ... Class III Micro Labs Usa, 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.