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Nearly 90,000 bottles of ibuprofen for children have been recalled due to the possible presence of a foreign substance, according to the Food and Drug Administration.
Strides Pharma, Inc., headquartered in India, has recalled approximately 89,592 bottles of its 100-milligram pediatric ibuprofen oral suspension, the FDA said.
The affected product was manufactured for Taro Pharmaceuticals USA and distributed in the US
The ibuprofen was sold in 4 fluid-ounce bottles with a dose of 100 milligrams per 5 milliliters.
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Nearly 90,000 bottles of ibuprofen for children have been recalled. (Getty Images / Getty Images)
The packages contain lot numbers 7261973A and 7261974A with an expiration date of January 31, 2027.
The recall was first issued earlier this month after complaints about 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 in the US (iStock / iStock)
But the FDA updated the classification this week to a Class II recall, meaning that “use of or exposure to a harmful product may cause temporary or medically reversible adverse health effects or the likelihood of serious adverse health effects 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 have purchased the recalled ibuprofen are urged to stop taking it immediately.
Parents who have concerns after a child consumes the product should consult a healthcare provider.
