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A nationwide recall of nearly 90,000 bottles of children’s ibuprofen has been upgraded to Class II, the Food and Drug Administration’s second-highest level of recall, following reports that the medication contained a “foreign substance.”
Earlier this month, Strides Pharma, Inc., a pharmaceutical company headquartered in India, recalled 89,592 bottles of Children’s Ibuprofen Oral Suspension, USP after reports of a “gel-like mass and black particles” in the product, the FDA says.
The affected medication, manufactured for Taro Pharmaceuticals USA, Inc., was distributed nationwide and sold in 4-fluid-ounce (120 mL) bottles at a concentration of 100 mg per 5 mL. Consumers were specifically advised to check bottles with lot numbers 7261973A and 7261974A, which carry an expiration date of January 31, 2027.
The FDA’s Class II designation indicates that while the contaminated ibuprofen may pose temporary health risks, the probability of serious or permanent harm is low.
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Strides Pharma, Inc. recalled 89,592 bottles of Children’s Ibuprofen Oral Suspension, USP after reports of a reported gel-like mass and black particles in the product (DailyMed)
In its guidance, the agency explains that a Class II recall applies to situations in which exposure to a defective or contaminated product could cause temporary or medically reversible adverse health effects, while serious or long-term consequences are considered unlikely.
Although no injuries or illnesses have been reported in connection with the recalled medication, parents and child caregivers are urged to check their medicine cabinets and stop use of any affected bottles immediately.
Consumers should also contact the place of purchase or the manufacturer for information about refunds or replacements.