FDA Updates Recall Classification for Children’s Ibuprofen Over Contamination Concerns

The U.S. Food and Drug Administration has updated the risk classification for a nationwide recall of children’s ibuprofen after reports the medication may contain foreign material.

Strides Pharma Inc. initiated the voluntary recall on March 2, 2026, involving 89,592 bottles of Children’s Ibuprofen Oral Suspension. The product, manufactured for Taro Pharmaceuticals U.S.A., Inc., was distributed nationwide.

According to the FDA enforcement report, the recall was prompted by consumer complaints describing the presence of a “gel-like mass and black particles” inside some bottles of the liquid medication. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=218947

The affected product is Children’s Ibuprofen Oral Suspension, USP, 100 milligrams per 5 milliliters, packaged in 4-fluid-ounce (120 mL) bottles. It carries the National Drug Code (NDC) 51672-5321-8 and was manufactured in India.

The recall applies specifically to lot numbers 7261973A and 7261974A, both with an expiration date of January 31, 2027.

The FDA has classified the recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, though the likelihood of serious harm is considered low.

The recall remains ongoing, and the company has notified distributors and the public through official communication.

Consumers who have purchased the affected ibuprofen are advised to stop using it immediately and check the lot numbers on their bottles. Anyone with concerns about potential exposure or adverse effects should contact a healthcare provider.

The FDA continues to monitor the situation under recall number D-0390-2026.