About 90,000 bottles of children’s ibuprofen have been recalled in the United States over contamination concerns, the U.S. Food and Drug Administration has said.
The agency disclosed in its enforcement report that 89,592 bottles of the liquid medication are affected. The recall was initiated by Strides Pharma following complaints from consumers who reported seeing a “gel-like mass and black particles” in the product.
The ibuprofen, produced in India for Taro Pharmaceuticals, was distributed nationwide and is widely used to treat fever and pain in children.
Affected units are 4-fluid-ounce bottles of Children’s Ibuprofen Oral Suspension, specifically those with lot numbers 7261973A and 7261974A and an expiration date of January 31, 2027.
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The FDA has classified the recall as Class II, indicating that “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.”
The recall began on March 2 and was later updated to reflect the Class II risk level on March 16.
While the action is largely focused on removing the product from retail outlets, the FDA advised consumers who may already have the medication to stop using it. Caregivers are urged to seek medical advice if a child has taken the affected product.