Infants' Ibuprofen Concentrated Oral Suspension that was voluntarily recalled because it could contain a higher concentration of ibuprofen has been expanded to include 3 three additional lots of medicine.

The additional medicine recalled is Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level.

  • 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

There is a possibility that babies may be more susceptible to a higher potency level of Ibuprofen, and could cause renal injury. Adverse effects could include nausea, vomiting, epigastric pain, diarrhea, tinnitus, headache, and gastrointestinal bleeding. There have been no reports of adverse events related to the recalled medicined.

The six lots of recalled pain reliever/fever reducer and was packaged in ½ oz. , 0.5 oz.  1oz. bottles listed below:

fda.gov

Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00 am ET- 5:00 pm 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.