Children’s Ibuprofen Recall: 90K Bottles Pulled Over Contamination | FDA Update

Nearly 90,000 bottles of children’s ibuprofen oral suspension are being voluntarily recalled nationwide due to potential contamination, the U.S. Food and Drug Administration announced Friday.

The recall affects products manufactured by Strides Pharma Inc. In India for Taro Pharmaceuticals U.S.A., Inc., according to the FDA. Customers reported finding “a gel-like mass and black particles” within the liquid medication, prompting the voluntary action initiated on March 2nd, the agency stated.

The recalled product is Children’s Ibuprofen Oral Suspension USP, 100 mg per 5mL, packaged in 4 fl. Oz. (120 mL) bottles. Specific lot numbers included in the recall are 7261973A and 7261974A, with an expiration date of January 31, 2027. The product is identified by NDC 51672-5321-8.

The FDA has classified the recall as Class II, indicating that while the risk of serious adverse health consequences is considered “remote,” use or exposure to the affected product could cause temporary or medically reversible health issues.

The medication is a berry-flavored solution recommended for children between the ages of 2 and 11, intended for the relief of pain associated with common ailments like colds, flu, sore throats, headaches, and toothaches, as well as fever reduction, according to Taro Pharmaceuticals’ website.

Neither Strides Pharma Inc. Nor Taro Pharmaceuticals U.S.A., Inc. Immediately responded to requests for comment Friday, the Associated Press reported.

The FDA notice did not specify the nature of the “black specs” or the “gel-like mass” found in the affected bottles, and further investigation is ongoing.