Tris Pharma, Inc. is expanding its recall of infants’ ibuprofen to include three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL.

The New Jersey-based pharmaceutical company originally recalled the liquid infant ibuprofen in November 2018 due to a higher concentration of ibuprofen than advertised.

According to the recall, some of the lots have been found to contain Ibuprofen as high as 10 percent above the limit.

So far there have been no reported incidents related to the recall.

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The FDA says that the company has already arranged a return of the recalled product from retailers and distributors.

The recall includes the following lots:

  • CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle
  • Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle
  • CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle
  • Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
  • Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
  • Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
  • CVS Health: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
  • Family Wellness: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle

Tris Pharma, Inc. urges consumers to call their customer service line with any questions at 732-940-0358 or email micc_tris@vigilarebp.com