Three Lots of Infant Ibuprofen Recalled

Pharmaceutical company Tris Pharma Inc. is voluntarily recalling three lots of infant ibuprofen concentrated oral suspension, USP (NSAID) 50 mg per 1.25 mL, because it may contain high levels of ibuprofen that are dangerous to babies and could cause kidney damage. The over-the-counter liquid pain reliever and fever reducer meant for infants between the ages of 6 months and 23 months.

“There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury,” the recall announcement stated.

Photo: PRNewsfoto/Tris Pharma, Inc.

The potentially dangerous medication was sold in 0.5-ounce bottles under three different brands at three different stores—Walmart, Family Dollar, and CVS.

Walmart, branded as Equate

  • national drug code 49035-125-23
  • lot number 00717009A with an expiration date of February 2019
  • lot number 00717015A with an expiration date of April 2019
  • lot number 00717024A with an expiration date of August 2019

Family Dollar, Branded as Family Wellness

  • national drug code 55319-250-23
  • lot number 00717024A with an expiration date of August 2019
Photo: PRNewsfoto/Tris Pharma, Inc.


  • national drug code of 59779-925-23
  • lot number 00717024A with an expiration date of August 2019

Retailers have been asked to discontinue selling this medication, and Tris Pharma is arranging for it to be returned. Consumers who have this medication at home should not use the medication and should throw it away.

Potential adverse effects could include nausea, vomiting, upper abdominal pain, diarrhea, gastrointestinal pain, ringing in the ears and headache, although no adverse health effects related to the recalled ibuprofen have been reported at this time. If you have given this medication to a child, please consult a physician about any concerns you may have regarding the child’s health.

Photo: PRNewsfoto/Tris Pharma, Inc.

You can also contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at the address listed on this page. Please report any adverse effects to the FDA’s MedWatch Adverse Event Reporting program.

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