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.

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DateProductReasonClassFirm
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.