Nearly 90,000 bottles of children’s ibuprofen recalled nationwide

Federal officials say thousands of bottles may contain foreign material.

WASHINGTON — A pharmaceutical company has recalled nearly 90,000 bottles of children’s ibuprofen nationwide after complaints that the medication may contain a foreign substance, according to federal health officials.

Strides Pharma Inc., headquartered in India, is recalling about 89,592 bottles of Children’s Ibuprofen Oral Suspension, the U.S. Food and Drug Administration said in an enforcement report. The recall follows reports of a gel-like mass and black particles found in the product.

The FDA has classified the recall as Class II, meaning use of the affected medication could cause temporary or medically reversible health problems, while the risk of serious harm is considered remote.

The recalled medication is a 100-milligram per 5-milliliter oral suspension sold in 4-fluid-ounce bottles. The affected lot numbers are 7261973A and 7261974A, with an expiration date of Jan. 31, 2027. The recall number is D-0390-2026.

The product was manufactured by Strides Pharma for Taro Pharmaceuticals USA Inc. and distributed across the United States.

Health officials advise consumers who have the recalled ibuprofen to stop using it immediately. The FDA said it has not received reports of serious adverse health effects related to the recall.