Additional Coverage:
Nearly 90,000 Bottles of Children’s Ibuprofen Recalled Nationwide Due to “Foreign Substance”
The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of nearly 90,000 bottles of children’s ibuprofen. The recall, initiated by Strides Pharma Inc. of New Jersey, concerns their Children’s Ibuprofen Oral Suspension, USP, 100 mg per 5mL, sold in 4 fl oz (120 mL) bottles.
According to an FDA enforcement report, 89,592 bottles of the medication are being pulled from shelves due to the “presence of foreign substance.”
Details of the Recalled Product
The affected product is Strides Pharma’s 100 mg Children’s Ibuprofen Oral Suspension, USP, manufactured for Taro Pharmaceuticals USA, Inc. The specific lot numbers impacted are 7261973A and 7261974A, both with an expiration date of January 31, 2027. These bottles were distributed across the country.
Strides Pharma has not yet responded to requests for comment regarding the recall.
Reason for the Recall
The voluntary recall was initiated on March 2 following consumer complaints describing “a gel-like mass and black particles” found within the medicine. On Monday, the FDA classified this as a Class II recall.
A Class II recall, as defined by the FDA, indicates “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.”
What to Do If You Have the Recalled Product
Consumers who possess the recalled children’s ibuprofen are advised to immediately stop using the product. Further information regarding next steps for consumers was not provided in the initial report.