Foreign substance prompts recall of children's ibuprofen by FDA

The Food and Drug Administration announced the Class II recall of nearly 90,000 bottles of children’s medication.

The FDA said that 89,592 bottles of Children’s Ibuprofen Oral Suspension were recalled. The dosage is 100 mg per 5mL. The bottles held 4 fl. oz. (120 mL) and were made for Taro Pharmaceuticals.

The recall is due to a foreign substance in the medication after the company received complaints of a gel-like mass and black particles in the liquid.

The recalled medication has Lot 7261973A or 7261974A and expiration date 01/31/2027.

The recall was initially issued on March 2, but the FDA classified it as a Class II on March 16.

A Class II recall is "a situation in which 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 FDA said.