The US Food and Drug Administration (FDA) has announced a recall of nearly 90,000 bottles of children's ibuprofen after complaints of contamination. Strides Pharma, Inc. is recalling 89,592 bottles of its Children’s Ibuprofen Oral Suspension, USP, 100mg per 5mL, distributed nationwide.
The recall applies to 4-ounce (120mL) bottles manufactured for Taro Pharmaceuticals. The medication, sold across the US but made in India, is a liquid pain reliever and fever reducer intended for children.
The FDA stated it received complaints of foreign substances in the medication, including a gel-like mass and black particles. The recall was initiated earlier this month and classified as Class II on Monday, indicating that exposure may cause temporary or medically reversible adverse health consequences, though the probability of serious harm is remote.
The recalled products have lot numbers 7261973A and 7261974A with an expiration date of January 31, 2027. It is not known how the foreign substances entered the medication or how many bottles are contaminated. The substances could pose a choking hazard to children, but no injuries or illnesses have been reported.
This recall follows a similar incident in December, when Gold Star Distribution recalled all FDA-regulated products from its Minneapolis facility due to rodent and bird droppings contamination, affecting brands like DayQuil, Tylenol, and Advil.
