FDA recalls children’s ibuprofen over reports of gel-like mass and black particles

(WVVA) – The FDA says Strides Pharma, Inc. is recalling 89,592 bottles of children’s ibuprofen after the company received complaints about a gel-like mass and black particles in the product.

The recall involves Children’s Ibuprofen Oral Suspension, USP, 100 mg per 5mL, in a 4 fl oz (120 mL) bottle. The product was manufactured for Taro Pharmaceuticals U.S.A., Inc. and distributed nationwide, according to the FDA’s enforcement report.

The recalled lots are 7261973A and 7261974A, with an expiration date of Jan. 31, 2027. The FDA lists the recall as Class II, meaning use of the product may cause temporary or medically reversible adverse health consequences, or the probability of serious consequences is considered remote.

The recall is listed as voluntary and ongoing, with a recall initiation date of March 2.

What to checkProduct: Children’s Ibuprofen Oral Suspension, USP, 100 mg per 5mLSize: 4 fl oz (120 mL) bottleLots: 7261973A, 7261974AExp: Jan. 31, 2027NDC: 51672-5321-8

FDA recalls children’s ibuprofen over reports of gel-like mass and black particles

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