Nearly 90,000 bottles of children's ibuprofen recalled due to 'foreign substance'

The U.S. Food and Drug Administration has announced that nearly 90,000 bottles of children’s ibuprofen sold nationwide have been recalled.

In an enforcement report, the federal agency said that 89,592 bottles of Strides Pharma’s Children’s Ibuprofen Oral Suspension are being recalled due to the “presence of foreign substance.”

Here’s what to know about the recall.

What children’s ibuprofen is affected?

Strides Pharma’s 100 mg Children’s Ibuprofen Oral Suspension, USP, 100 mg per 5mL, sold in 4 fl oz (120 mL) bottles were manufactured for Taro Pharmaceuticals USA, Inc., before being distributed across the country.

The report said the recall was voluntary and initiated by Strides Pharma Inc., located in New Jersey.

The impacted children’s ibuprofen has lot numbers of 7261973A and 7261974A, with an expiration date of Jan. 31, 2027.

Strides Pharma did not immediately respond to a request for a comment.

Why was it recalled?

The products were removed following complaints describing “a gel-like mass and black particles” in the medicine, the FDA said.

Following the complaints, the recall was initiated on March 2, the report said. The FDA labeled the recall as Class II on Monday.

A Class II recall involves “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,” according to the FDA’s website.

What to do if you have the recalled product?

People should immediately stop using the recalled product. No additional information about next steps was shared in the report.