Nearly 90,000 bottles of children’s ibuprofen have been recalled because of the potential presence of a foreign substance, the Food and Drug Administration announced.
Strides Pharma Inc., based in India, recalled about 89,592 bottles of its 100-milligram Children’s Ibuprofen Oral Suspension.
The product was manufactured for Taro Pharmaceuticals USA and distributed nationwide.
The medicine was sold in 4-fluid-ounce bottles containing 100 milligrams per 5 milliliters. Affected bottles carry lot numbers 7261973A and 7261974A and expire January 31, 2027.
The recall was initiated earlier this month after consumers reported a gel-like mass and black particles in the product. The FDA classified it as a Class II recall on March 16, meaning use of the product may cause temporary or medically reversible health problems or carry a remote chance of serious adverse effects.
Consumers should immediately stop using the recalled ibuprofen. Parents whose children may have taken it are advised to contact a health care provider with any concerns.
In 2020, Taro Pharmaceuticals USA was charged with “participating in two conspiracies to suppress and eliminate competition by agreeing to fix prices, allocate customers, and rig bids for generic drugs. The charged conspiracies took place between 2013 and 2015,” according to the Department of Justice.
