Children’s Ibuprofen Recall: 90,000 Bottles Affected – FDA Alert

Nearly 90,000 bottles of children’s ibuprofen oral suspension have been recalled nationwide due to potential contamination, the U.S. Food and Drug Administration (FDA) announced Tuesday.

The recall affects 89,592 bottles of Children’s Ibuprofen Oral Suspension manufactured by Strides Pharma Inc. For Taro Pharmaceuticals USA, Inc., according to the FDA. The agency initiated the recall after receiving reports of a “gel-like mass and black particles” found within the medication.

The recalled product is a 100-milligram oral suspension sold in 4-fluid-ounce bottles. Lot numbers 7261973A and 7261974A, with an expiration date of January 31, 2027, are subject to the recall, identified by recall number D-0390-2026.

The FDA categorized the recall as a Class II recall, indicating that while use or exposure to the affected product may cause temporary or medically reversible health consequences, the probability of serious adverse health effects is considered remote.

Strides Pharma, headquartered in India, manufactures generic and over-the-counter medicines for distribution in the U.S. And other countries. The company initiated the recall, the FDA stated. Taro Pharmaceuticals’ website indicates the Children’s Ibuprofen Oral Suspension is a berry-flavored solution recommended for children ages 2 to 11.

Consumers who have purchased the recalled ibuprofen are advised to discontinue use immediately.

As of Friday morning, neither Strides Pharma nor Taro Pharmaceuticals had responded to requests for comment regarding the recall, according to the Associated Press.