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FDA Recalls Nearly 90,000 Bottles of Children’s Ibuprofen

The Food and Drug Administration (FDA) has announced a nationwide recall of nearly 90,000 bottles of children’s ibuprofen distributed across the United States due to potential contamination with a foreign substance. The recall applies to 100-milligram Children’s Ibuprofen Oral Suspension manufactured by Strides Pharma, Inc. for Taro Pharmaceuticals USA.

Details of the Recalled Product

The affected ibuprofen was sold in 4-fluid-ounce bottles, each containing 100 milligrams per 5 milliliters. The recalled lots carry the numbers 7261973A and 7261974A, with an expiration date of January 31, 2027. The recall was initiated after complaints about the product containing a gel-like mass and black particles.

FDA Classification and Consumer Guidance

The FDA updated the recall classification to Class II, indicating that exposure to the product may cause temporary or medically reversible adverse health effects, while the likelihood of serious health consequences is remote. This classification is the FDA’s second-highest urgency level for recalls.

Consumers who purchased the recalled ibuprofen are advised to discontinue use immediately. Parents concerned that their child has consumed the product should seek advice from a healthcare provider.

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FDA Recalls Nearly 90,000 Bottles of Children’s Ibuprofen

FDA Recalls Nearly 90,000 Bottles of Children’s Ibuprofen

FDA Recalls Nearly 90,000 Bottles of Children’s Ibuprofen