FDA RECALL: Nearly 90,000 Bottles of Children’s Ibuprofen Pulled for Contamination Concerns

FDA lists Class II recall after reports of gel‑like clumps and black particles in liquid medicine

A nationwide recall is underway after the U.S. Food and Drug Administration announced that nearly 90,000 bottles of Children’s Ibuprofen Oral Suspension have been pulled from shelves due to contamination concerns.

According to the FDA’s Enforcement Report, the recall covers 89,592 bottles of Children’s Ibuprofen Oral Suspension, 100 mg per 5 mL (4‑oz bottles) manufactured by Strides Pharma Inc. for Taro Pharmaceuticals U.S.A. The affected lots—7261973A and 7261974A—carry an expiration date of January 31, 2027

The recall was initiated after multiple consumer complaints describing gel‑like masses and black particles floating in the liquid medication. The FDA classified the action as a Class II recall, indicating the product defect may cause temporary or medically reversible health effects, with a low likelihood of serious injury.

The recalled bottles were distributed nationwide

Parents and caregivers are urged to stop using the affected product immediately and check any bottles at home for the listed lot numbers. Adverse reactions or product quality issues can be reported through FDA MedWatch at fda.gov/medwatch or by calling 1‑800‑FDA‑1088.

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