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Three lots of Infants’ Ibuprofen recalled due to potentially high concentrations of ibuprofen

MONMOUTH JUNCTION, NJ. (HCBN)- A voluntary recall has been issued for three lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL. Potentially higher concentrations of ibuprofen have been found in the lots, prompting the recall, according to Tris Pharma, Inc.

“There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects,” says Tris Pharma, Inc. in a statement regarding the recall.

Tris Pharma adds that they have not received any reports of adverse events related to the recall, as of yet.

Equate, CVS Health, and Family Wellness brands are the affected brands. These brands were distributed nationwide.

Tris Pharma, Inc. says that the company has notified its customers of the urgent recall and are in the process of arranging for the return of the recalled products.

“Wholesalers and retailers of the product should stop further distribution of the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, which are being recalled.”

If a consumer has questions about this recall, they are urged to contact Tris Customer Service at 732-940-0358 or by email at

Consumers are advised to contact their healthcare provider if they are possibly experiencing any issues relating to this product.

The image below, as provided by Tris Pharma, Inc., shows the exact products affected by this recall.

The images used in this article were provided by Tris Pharma, Inc.


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