Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Recalled by Glaxosmithkline Consumer Healthcare Holdings Due to Labeling: Lacks Warning or Rx Legend- Certain lots...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Glaxosmithkline Consumer Healthcare Holdings directly.
Affected Products
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)
Quantity: 151,056 bottles
Why Was This Recalled?
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Where Was This Sold?
Product was distributed throughout the United States, including Puerto Rico.
About Glaxosmithkline Consumer Healthcare Holdings
Glaxosmithkline Consumer Healthcare Holdings has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report