Infant Ibuprofen Recall Expanded to Additional Batches at CVS, Walmart

Tris Pharma issued an expanded voluntary recall of its infant liquid ibuprofen sold at CVS and Walmart over safety concerns, according to the FDA’s recall notice. The company initially recalled this product in both stores and Family Dollar in December. Now, Tris Pharma has recalled three new lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml.

Some units from the lots contain doses of ibuprofen as high as 10 percent above the specified limits. Safety issues or toxicity is typically a concern in infants at doses in excess of 700 percent of the recommended dose, according to studies. At the time of this announcement, there have been no reports related to the recall.

The updated recall includes the six lots listed below:

• CVS: Lot No. 4718 (12/19 expiration date); lot No. 00717006A (2/19 expiration date); and the previously reported lot No. 00717024A (8/19 expiration date)
• Walmart: Lot. No. 00717005A (2/19 expiration date); previously reported lot No. 00717009A (2/19 expiration date); previously reported lot No. 00717015A (4/19 expiration date); and previously reported lot No. 00717024A (8/19 expiration date)
• Family Dollar: Previously reported lot No. 00717024A (8/19 expiration date)

More information on the recall is available in the FDA’s full announcement, and you can contact Tris customer service at 732-940-0358 with any questions.

Please note: The Bump and the materials and information it contains are not intended to, and do not constitute, medical or other health advice or diagnosis and should not be used as such. You should always consult with a qualified physician or health professional about your specific circumstances.