U.S. Food and Drug Administration sent this bulletin at 11/17/2023 02:38 PM EST

November 13, 2023, Los Angeles, California – KinderFarms, LLC is voluntarily recalling all lots of KinderMed Infants’ Pain & Fever (oral suspension) and KinderMed Kids’ Pain & Fever (oral suspension) to the retail and consumer level. These products are being voluntarily recalled due to acetaminophen instability. The two products were manufactured and packaged for KinderFarms by a major, U.S.-based OTC pharmaceutical manufacturer with over 30 years of experience. Ongoing testing of sample batches indicated some product lots were no longer in specification and may pose a health risk. Out of an abundance of caution, KinderFarms has made the decision to voluntarily recall all KinderMed Pain & Fever products.

Acetaminophen is the active ingredient in many pain-relieving medicines. As a result of the potential health risk with acetaminophen being outside of specification, the product may cause acute adverse health effects, including abdominal pain, nausea, vomiting or jaundice at higher doses.