NATIONWIDE — Tris Pharma has voluntarily recalled three lots of its Infants’ Ibuprofen, the company announced Wednesday.

  • Tris Pharma: Infants' Ibuprofen concentrated oral suspension recalled
  • 3 recalled lots sold at Walmart, CVS Pharmacy, Family Dollar

The recall applies to its “Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL” product, which is sold at Walmart, Family Dollar, and CVS Pharmacy.

The product is used to help fever reduction and pain relief. The recalled lots were discovered to have potentially higher concentrations of ibuprofen, according to the company in a press release.

The following lots, packaged in 0.5 oz. bottles, are being recalled:

Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle

  • Sold at Wal-Mart Stores Inc.
  • NDC: 49035-125-23
  • Lots: 00717009A, 00717015A, 00717024A
  • Expiration dates: 02/19, 04/19, 08/19

CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle

  • Sold at CVS Pharmacy
  • NDC: 59779-925-23
  • Lot: 00717024A
  • Expiration date: 08/19

Family Wellness: Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle

  • Sold at Family Dollar
  • NDC: 55319-250-23
  • Lot: 00717024A
  • Expiration date: 08/19

Tris Pharma says there is a “remote possibility” that infants who are more susceptible to higher levels of drug potency may be vulnerable to “NSAID-associated renal injury.” Possible side effects include nausea, vomiting, epigastric pain, diarrhea, tinnitus, headache, and gastrointestinal bleeding.

According to the company, they haven’t received any complaints about the lots involved in the recall.

Anyone with questions is encouraged to call Tris Customer Service at 732-940-0358.