Browse Drug Recalls
12 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 12 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 12 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 5, 2025 | Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIEL... | Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/W... | Class III | Haleon US Holdings LLC |
| Dec 26, 2023 | Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorph... | Microbial Contamination of Non-Sterile Products | Class I | Haleon US Holdings LLC |
| Dec 26, 2023 | Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramin... | Microbial Contamination of Non-Sterile Products | Class I | Haleon US Holdings LLC |
| May 28, 2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distrib... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single p... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 ... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distri... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Dec 23, 2019 | Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per car... | Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the prod... | Class II | GSK Consumer Health, Inc |
| Sep 26, 2018 | Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per... | CGMP deviations | Class II | GLAXOSMITHKLINE NEBRASKA |
| Jun 28, 2017 | parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigi... | Presence of Foreign Substance: possibility of the presence of metal in the product. | Class II | GSK Consumer Healthcare |
| Mar 6, 2017 | Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v flu... | Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli... | Class II | GSK Consumer Healthcare |
| Oct 18, 2016 | Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 O... | Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of... | Class III | GSK Consumer Healthcare |
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.