Tris Pharmaceuticals Recalls Infants’ Ibuprofen

December 5, 2018 – Tris Pharmaceuticals has voluntarily recalled three lots of over-the-counter (OTC) 50mg/1.25mL Infants’ Ibuprofen Concentrated Oral Suspension. The recalled products may contain a higher concentration of ibuprofen than specified.

According to the recall announcement, there is a remote possibility that infants may be at risk of kidney injury if given ibuprofen from the affected lots. The manufacturer has not received any reports of adverse events as of the date of the recall.

Consumers can direct questions to Tris Customer Service at 732-940-0358 or micc_tris@vigilarebp.com. Any adverse events that may be related to use of the recalled product should be reported to the consumer’s healthcare provider, and can also be submitted to the FDA MedWatch program.

Additional information can be found at: https://www.fda.gov/Safety/Recalls/ucm627780.htm