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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
Apr 16, 2015 Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL) Products failed the Antimicrobial Effectiveness Test Class II Tarmac Products, Inc.
Apr 16, 2015 Well at Walgreens Regular Strength Antacid Liquid, Mint Flavor 12 FL OZ (355 ... Products failed the Antimicrobial Effectiveness Test. Class II Tarmac Products, Inc.
Apr 16, 2015 Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ (355 mL) bottle, Products failed the Antimicrobial Effectiveness Test Class II Tarmac Products, Inc.
Feb 6, 2015 Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg... Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-mo... Class II Tarmac Products, Inc.
Mar 16, 2013 "Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simeth... Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count ... Class II Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals

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.