Nearly 90,000 Bottles of Children's Ibuprofen Recalled Over Black Particles, Gel-Like Contamination

Strides Pharma Inc. voluntarily recalled about 89,592 bottles of Children's Ibuprofen Oral Suspension in early March after consumers reported finding "a gel-like mass and black particles" in the berry-flavored liquid, the FDA confirmed under recall number D-0390-2026. The affected product was manufactured in India by Strides for Taro Pharmaceuticals U.S.A., Inc. and distributed nationwide across the United States.

The recall covers 4-fluid-ounce bottles of the 100 milligrams per 5 milliliters concentration, specifically lot numbers 7261973A and 7261974A, both carrying an expiration date of January 31, 2027. According to Taro's product description, the liquid ibuprofen is intended for children ages 2 to 11 and is formulated to reduce pain and fever.

CBS News reported that Strides initiated the recall on March 2 after the company received complaints describing the contamination as a foreign substance. On March 16, the FDA elevated the action to a Class II recall, which the agency defines as a situation where "use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." Fox Business noted that Class II is the FDA's second-highest urgency level.

Strides Pharma, which produces generic and over-the-counter medicines for companies in the U.S. and numerous other countries, is headquartered in India. Neither Strides nor Taro Pharmaceuticals responded to requests for comment from multiple news outlets, including the Associated Press.

Parents who purchased the affected product should check lot numbers against 7261973A and 7261974A and consult the FDA's online notice for recall D-0390-2026 for official guidance on returning or disposing of the bottles.