Infants' Ibuprofen Concentrated Oral Suspension has been voluntarily recalled because it could contain a higher concentration of ibuprofen.

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 recalled pain reliever/fever reducer and was packaged in 0.5 oz. Bottles for the recalled lots listed below:

Tris Pharmacies/PRNewswire

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.