Recall of Infant Ibuprofen Sold at CVS Has Been Expanded Due to Safety Concerns

Last November, we gave you some very scary news, alerting you to the dangers that may be lurking in your kid’s medicine cabinet. You see, the drugmaker, Tris Pharma, Inc., issued a voluntary recall after it was found that its generic form of Infant’s Ibuprofen contained higher amounts of ibuprofen per dose than what was written on the label. Now, nearly two months later, the company has expanded its recall to include even more lots of its product.

In a January 29th news release published by the FDA, Tris Pharma, Inc., announced that it was including three additional lots of its Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL in the recall. Here are the affected medicines, along with their retailers. (Remember, this Tris Pharma, Inc. drug was only being sold as a generic product):

  • Walmart: Equate label. National Drug Code (NDC): 49035-125-23; Lot numbers: 00717005A, 00717009A, 00717015A and 00717024A .
  • CVS: CVS Health label. National Drug Code (NDC): 59779-925-23; Lot numbers: 4718, 00717006A and 00717024A.
  • Family Dollar: Family Wellness label. National Drug Code (NDC): 55319-250-23. Lot number: 00717024A.

Experts from the government health agency warn that some infants could become sickened, even permanently so, if given the tainted drug. The FDA writes:

Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury.

Although no serious adverse effects have been reported to the FDA as of yet, it’s important that all parents remain vigilant about this widespread recall. If you believe that your infant has become ill after taking the medication, contact their pediatrician immediately.

If you have any questions or concerns about the original purchase of the Ibuprofen Oral Suspension Drops, you can call Tris Customer Service at 732-940-0358, or you can email them at [email protected]

And, for even more information on this expanded recall, be sure to watch the video below!







What are your thoughts on this expanded recall? Did you buy the product? Is your infant sensitive to ibuprofen?