Browse Drug Recalls
17 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17 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 17 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 6, 2022 | Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 05... | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... | Class I | Glaxosmithkline Consumer Healthcare Holdings DB... |
| Dec 6, 2022 | Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever ... | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... | Class I | Glaxosmithkline Consumer Healthcare Holdings DB... |
| Dec 6, 2022 | Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Relieve... | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... | Class I | Glaxosmithkline Consumer Healthcare Holdings DB... |
| Jun 16, 2020 | Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (c... | Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Jun 16, 2020 | Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (23... | Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| 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 |
| Apr 20, 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ... | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... | Class III | Glaxosmithkline Consumer Healthcare Holdings |
| Apr 20, 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08... | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... | Class III | Glaxosmithkline Consumer Healthcare Holdings |
| Apr 20, 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ... | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... | Class III | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 16, 2020 | Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops ... | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 16, 2020 | Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F005... | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 16, 2020 | Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with... | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 16, 2020 | Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. A... | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 16, 2020 | Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bot... | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
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.