Infant Ibuprofen Recall

Tris Pharma, Inc. has issued a voluntary nationwide recall of infant ibuprofen amid concerns the medication, which was destined to be sold at several major retailers, may contain a higher concentration of ibuprofen than labeled. The lots were sold under Walmart, CVS Pharmacy and Family Dollar. As of now, the company has not received any reports of serious adverse events related to the recall.

Why is it being recalled?

Per Tris Pharma, “The reason for the recall was a potential higher concentration of Ibuprofen of less than 10% above the specified limit in some bottles from these three batches. Safety issues or toxicity is generally accepted to be a concern in infants at doses more than 700% of the recommended dose.” If Ibuprofen is taken in excess, a side effect could be permanent kidney injury, nausea, vomiting, stomach pain, diarrhea, tinnitus, headaches or possible stomach bleeding.

What products are recalled?

Affected products are labeled “Infants’ Ibuprofen Concentrated Oral Suspension” and were labeled to contain 50 mg. of ibuprofen per 1.25 mL. 

NDC; LOT; EXPIRATION; DESCRIPTION ; COMPANY;
49035-125-23 00717009A
00717015A
00717024A
02/19
04/19
08/19
Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle Wal-Mart Stores Inc
59779-925-23 00717024A 08/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle CVS Pharmacy
55319-250-23 00717024A 08/19 Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle Family Dollar Services Inc.

Next steps you should take

  • To determine whether a specific product has been recalled, patients should look at the drug name and see if the NDC, Lot, and expiration dates matches those listed above.
  • If you have one of the recalled medicines, follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
  • Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. 

Need help?

Contact your Tria Health pharmacist today for additional assistance with the recall process: 1.888.799.8742

Source: https://www.fda.gov/Safety/Recalls/ucm627780.htm