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Product Recall Expansion: Infants’ Pain Reliever/Fever Reducer

The U.S. Food and Drug Administration says Tris Pharma, Inc. has expanded the scope of its 11/2018 recall, adding three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL. Some units from these batches were found to have higher levels of Ibuprofen concentration. Tris Pharma, Inc. had initially voluntarily recalled three lots for the same reason. This pain reliever/fever reducer was packaged in 0.5 oz. bottles for the recalled lots listed on the FDA website.