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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
Mar 30, 2017 Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium... Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister... Class II Bayer HealthCare Pharmaceuticals, Inc.
Mar 30, 2017 Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium b... Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister... Class II Bayer HealthCare Pharmaceuticals, Inc.
Mar 30, 2017 Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bic... Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister... Class II Bayer HealthCare Pharmaceuticals, Inc.
Dec 7, 2012 Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifen... Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from t... Class III Bayer Healthcare, LLC
Apr 26, 2012 Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a)... Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on t... Class III Bayer Healthcare, LLC
Apr 26, 2012 Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. b... Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on t... Class III Bayer Healthcare, LLC

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.