FDA Recalls 89,592 Bottles of Children's Ibuprofen Over Contaminants

Federal regulators have recalled nearly 90,000 bottles of a children's pain reliever distributed across the United States after consumers reported finding black particles and a gel-like mass in the product.

The Food and Drug Administration announced the Class II recall on March 20, 2026, involving 89,592 bottles of Taro Pharmaceuticals Children's Ibuprofen Oral Suspension, USP, 100 mg per 5 mL. The berry-flavored liquid, intended for children ages 2 to 11 to treat fever and pain, comes in 4-ounce (120 mL) bottles with lot numbers 7261973A and 7261974A, expiring on January 31, 2027. The product's National Drug Code is 51672-532-18.

Strides Pharma Inc., an India-based manufacturer with operations in the United States, initiated the voluntary recall on March 2, 2026, following customer complaints about the contaminants. The FDA classified it two weeks later, on March 16, as a Class II action, indicating that use of the product may cause temporary or medically reversible health effects, though the risk of serious adverse consequences remains remote. No illnesses or injuries have been reported in connection with the affected lots.

The medication was produced at Strides' facilities in...