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4d ago

FDA Upgrades Children’s Ibuprofen Recall to Class II Over Reports of Foreign Material

Reports of gel-like material, including black particles, in two nationwide lots triggered the FDA’s action.

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FILE - A sign for the U.S. Food and Drug Administration is displayed outside their offices in Silver Spring, Md., Dec. 10, 2020. (AP Photo/Manuel Balce Ceneta, File)

Overview

  • Strides Pharma voluntarily recalled 89,592 bottles of Children’s Ibuprofen Oral Suspension (100 mg per 5 mL) sold in 4‑fluid‑ounce bottles.
  • Affected lots are 7261973A and 7261974A with an expiration date of January 31, 2027; the product was manufactured for Taro Pharmaceuticals USA and distributed nationwide.
  • The FDA designated the recall Class II on March 16, indicating possible temporary or medically reversible health effects with a low probability of serious harm.
  • No injuries or illnesses have been reported; consumers should stop use, verify lot numbers, seek refunds or replacements, consult a health care provider if concerned, and report issues to MedWatch.
  • The source of the foreign material has not been specified by regulators, with the investigation into the contamination pathway ongoing.