Strides Pharma Inc. has issued a nationwide recall for 89,592 bottles of Children’s Ibuprofen Oral Suspension following consumer reports of a “gel-like mass and black particles” contaminating the liquid medication. The U.S. Food and Drug Administration officially designated the action as a Class II recall on March 16. No serious injuries or illnesses have been reported in connection with the contaminated batches.
Affected Product Details
The voluntary recall, initially launched on March 2, specifically targets the 100 mg per 5 mL dosage sold in 4-fluid-ounce (120 mL) bottles. The medication was manufactured in India by Strides Pharma for Taro Pharmaceuticals U.S.A., Inc., under the National Drug Code 51672-5321-8. Parents and caregivers are instructed to check their medication cabinets for lot numbers 7261973A and 7261974A.
Both affected lots carry an expiration date of January 31, 2027.
Health Risks And FDA Classification
The FDA defines a Class II recall as a situation where exposure to a violative product may cause temporary or medically reversible adverse health consequences, while the probability of serious adverse health consequences remains remote. Medical professionals advise caregivers to immediately cease using the identified lots and consult a pediatrician or Poison Control regarding any related medical concerns.
Multiple law firms have announced investigations into potential product liability claims stemming from the contamination. Legal representatives are advising affected families to preserve the unconsumed medication and document any associated medical monitoring expenses.