Children’s OTC Med Recalled

An acetaminophen instability has prompted KinderFarms to voluntarily recall all lots of the over-the-counter (OTC) medication KinderMed Kids’ Pain & Fever. The recall spans nearly 600,000 bottles, according to the December 13, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects KinderMed Kids’ Pain & Fever (acetaminophen 160 mg per 5 mL), oral suspension, organic cherry flavor, 4 fluid ounces/118 mL (NDC 82673-097-04, UPC 850001805728), from lots CJ70900 and CJ76796 (Exp. 8/24); CJ77051 (Exp. 9/24); WK02998, WK02997, WK04390, and WK02999 (Exp. 10/24); WK03716 (Exp. 12/24); WK05150, WK05151, and WK07174 (Exp. 2/25); WK05539 and WK06534 (Exp. 3/25); WK10259 and WK23040 (Exp. 4/25); and WK27455 (Exp. 8/25). The products were distributed throughout the United States by KinderFarms, Redondo Beach, California.

“The two products were manufactured and packaged for KinderFarms by a major, US-based OTC pharmaceutical manufacturer with over 30 years of experience,” KinderFarms stated in a November 13, 2023, company announcement. “Ongoing testing of sample batches indicated some product lots were no longer in specification and may pose a health risk.”

KinderFarms initiated the recall November 13, 2023. It was designated Class II by the FDA on December 6, 2023, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

“As a result of the potential health risk with acetaminophen being outside of specification,” KinderFarms stated, “the product may cause acute adverse health effects, including abdominal pain, nausea, vomiting or jaundice at higher doses.”

KinderMed Kids’ Pain & Fever is used to temporarily reduce fever and relieve minor aches and pains in children ages 2 to 11 years.