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
Jan 20, 2026 Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per... CGMP Deviations Class II ACME UNITED CORPORATION
Jan 24, 2022 Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count pac... cGMP deviations Class II Ultra Seal Corporation
Dec 6, 2021 Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 ... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Dec 6, 2021 Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Dec 6, 2021 Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID),... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products

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.