FDA recalls 90,000 bottles of children’s ibuprofen over foreign substance

Nearly 90,000 bottles of children’s ibuprofen have been recalled over the potential presence of a foreign substance, according to the Food and Drug Administration.

Strides Pharma, Inc., headquartered in India, recalled about 89,592 bottles of its 100-milligram Children’s Ibuprofen Oral Suspension, the FDA said. 

The affected product was manufactured for Taro Pharmaceuticals USA and distributed across the U.S.

The ibuprofen was sold in 4-fluid-ounce bottles at 100 milligrams per 5 milliliters.

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Nearly 90,000 bottles of children’s ibuprofen have been recalled. (Getty Images / Getty Images)

The packages included the lot numbers 7261973A and 7261974A with an expiration date of Jan. 31, 2027.

The recall was first issued earlier this month after complaints of a gel-like mass and black particles in the product.

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The affected product was manufactured for Taro Pharmaceuticals USA and distributed across the U.S. (iStock / iStock)

But the FDA updated the classification this week to a Class II recall, which means “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.”

The Class II classification is the FDA’s second-highest urgency level.

The Class II classification is the FDA’s second-highest urgency level. (Stefani Reynolds/Bloomberg via Getty Images / Getty Images)

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Consumers who purchased the recalled ibuprofen are urged to stop using it immediately.

Parents with concerns after a child has consumed the product should consult a healthcare provider.