Bottles of Children’s Ibuprofen Recalled Nationwide Over Contamination Concerns

Strides Pharma Inc, based in Bridgewater, New Jersey, has initiated a voluntary nationwide recall of Children’s Ibuprofen Oral Suspension, USP (100 mg per 5 mL) supplied in 4 fl oz (120 mL) bottles. The affected product, made in India and labeled under NDC 51672-5321-8, includes approximately 89 592 bottles from lots 7261973A and 7261974A, both with an expiration date of January 31, 2027. The recall was initiated on March 2, 2026, and remains ongoing, with notification to consignees conducted via letter.

The US Food and Drug Administration (FDA) has classified this action as a Class II recall, indicating that use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, with a remote probability of serious harm. No public press release has been issued. The recall is being carried out voluntarily by the firm, with oversight reflected in the FDA’s Enforcement Report and a center classification date of March 16, 2026.

The recall was prompted by complaints of foreign material contamination, specifically reports of a gel-like mass and black particles found within the oral suspension. Such contamination raises concerns about product quality and safety, particularly in pediatric populations. For pharmacist awareness, ibuprofen oral suspension is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the reduction of fever and relief of mild to moderate pain in children, commonly used for conditions such as headaches, toothaches, minor injuries, and symptoms associated with colds or flu.

Reference

FDA. Enforcement Report. March 16, 2026. Accessed March 19, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=218947