Children’s ibuprofen recalled nationwide after customer complaints of ‘gel-like mass and black particles’

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:

• 7261973A: Best by January 31, 2027
• 7261974A: Best by January 31, 2027

Where and when was the product sold?

Right now, all we know is that the children’s ibuprofen bottles were distributed nationwide.

The FDA report states that a letter was sent out to the public, but there’s no press release and specific details about how individuals were notified are not included in the report.

Media outlets only began reporting on the recall this week—despite that March 2 start date. 

Fast Company reached out to Strides Pharma and Taro Pharmaceuticals for more information and will update this story if we hear back.

What should I do if I have this product? 

Do not use any recalled ibuprofen if you have it. There’s no information yet about the potential for a refund or other next steps. 

This story is developing…

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