Browse Drug Recalls

66 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 66 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 66 FDA drug recalls.

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DateProductReasonClassFirm
Jan 24, 2022 AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine ... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 2... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 3... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahyd... cGMP deviations Class II Ultra Seal Corporation
Jan 24, 2022 Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, ... cGMP deviations Class II Ultra Seal Corporation
Oct 13, 2021 PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 ... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) t... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 6... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Aug 3, 2020 Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine ... Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... Class III Ultra Seal Corporation
Aug 3, 2020 Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65... Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... Class III Ultra Seal Corporation

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.