The U.S. Food and Drug Administration has announced a recall of nearly 90,000 bottles of children's ibuprofen over contamination
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Strides Pharma, the manufacturer of the product, initated the recall after reports of black particles and a gel-like substance inside the medication
Affected products include specific lot numbers with a 2027 expiration date
A widely used children's pain reliever is being pulled from shelves across the United States after reports of contamination, prompting a nationwide recall of nearly 90,000 bottles, according to the U.S. Food and Drug Administration (FDA).
In anenforcement report, the agency said 89,592 bottles of liquid children's ibuprofen are affected. The recall was initiated by the manufacturer, Strides Pharma, after the company received complaints describing a "gel-like mass and black particles" inside the medication.
The product, manufactured in India for Taro Pharmaceuticals, was distributed nationwide and is commonly used by parents to treat pain and fever in children. The recall applies specifically to 4-fluid-ounce bottles, with affected products identified by lot numbers 7261973A or 7261974A and an expiration date of Jan. 31, 2027.
Federal regulators classified the recall asClass II, a designation used when a product may cause temporary or medically reversible health effects, though the risk of serious harm is considered low. These recalls are typically carried out at the retail level, meaning products are removed from store shelves rather than homes, unless further action is advised, according to the FDA.
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Still, health experts urge caution. Parents and caregivers are advised to avoid giving children the recalled medication. If a child may have already consumed the product, concerned caregivers should contact a health care provider.
Additional guidance fromWhat to Expectrecommends consulting a pediatrician before administering any medication to a child under 2 years old.
PEOPLE has reached out to the FDA and Strides Pharma for comment.
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