RECALL ALERT: FDA recalls nearly 90,000 bottles of ibuprofen over foreign substance

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Are you buying ibuprofen manufactured in India?

From Fox Business: 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.


Earlier this month, there were complaints of a gel-like mass and black particles in the product, prompting a recall to be issued.

However, this week the FDA issued a Class II recall, which is the second-highest urgency level, used in cases where “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.”

A bulletin posted on the FDA website says the recall applies to 89,592 bottles, with an expiration date of 01/31/2027.

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