Nearly 90,000 bottles of children’s ibuprofen have been recalled across the United States, according to an enforcement report this week from the Food and Drug Administration (FDA).
Strides Pharma Inc. has recalled 89,952 bottles of Children’s Ibuprofen Oral Suspension following customer complaints of a “gel-like mass and black particles” in the medicine.
The India-based company had manufactured the ibuprofen for Taro Pharmaceuticals U.S.A., Inc. based in Hawthorne, New York. The recall comes from Strides Pharma’s Bridgewater, New Jersey, subsidiary.
Strides Pharma initiated the recall on March 2, with the FDA labeling it a Class II recall on Monday, March 16.
A Class II indicates a situation in which use or exposure to the product could cause “temporary or medically reversible adverse health consequences” with a very small possibility of serious adverse health consequences.
Wondering if your medicine is impacted? Here’s all the information we have on the ibuprofen recall.
What products are affected?
The impacted medication is Children’s Ibuprofen Oral Suspension, USP, 100 mg per 5mL, in 4 FL OZ (120 mL) bottles. Two lots are included in the recall:
