A nationwide recall of nearly 90,000 bottles of children's ibuprofen has been escalated to a Class II recall, the second-highest level by the US Food and Drug Administration (FDA), after reports of a foreign substance in the medication.
The recall, initiated earlier this month by Strides Pharma, Inc., an Indian pharmaceutical company, affects 89,592 bottles of Children’s Ibuprofen Oral Suspension, USP. The FDA reported that a “gel-like mass and black particles” were found in the product.
The medication, manufactured for Taro Pharmaceuticals USA, Inc., was distributed across the US and sold in 4-fluid-ounce (120 mL) bottles with a concentration of 100 mg per 5 mL. Consumers are advised to check bottles with lot numbers 7261973A and 7261974A, which expire on January 31, 2027.
The FDA's Class II designation indicates that while the contaminated ibuprofen may pose temporary health risks, the probability of serious or permanent harm is low. The agency states that exposure could cause temporary or medically reversible adverse effects, but serious consequences are unlikely.
No injuries or illnesses have been reported in connection with the recalled medication. Parents and caregivers are urged to check their medicine cabinets and immediately stop using any affected bottles. Consumers should contact the place of purchase or the manufacturer for refund or replacement information.
