Safety Report: KinderMed OTC Pain and Fever Reliever for Infants and Kids - recalled due to Acetaminophen Instability, USA

United States

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. These products are available nationwide in drug/pharmacy, supermarkets, direct delivery and national retailers, and online through major ecommerce sites. The company has not received any reports of serious adverse events from either of these products to date.

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. 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.

This voluntary recall encompasses all products currently available on shelf of these two SKUs only. The impacted product being voluntarily recalled is all lots of:
- KinderMed Infants’ Pain & Fever (2 fluid ounces/59 mL), (Acetaminophen - 160 mg per 5 mL), Oral Suspension. UPC: 850001805698
- KinderMed Kids’ Pain & Fever (4 fluid ounces/118 mL), (Acetaminophen - 160 mg per 5 mL), Oral Suspension. UPC: 850001805728

Consumers who purchased either of these two products should stop using them and may return the product to the place of purchase for a full refund.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: KinderFarms, LLC
Brand name: KinderMed
Product recalled: OTC Pain and Fever Reliever for Infants and Kids
Reason of the recall: Due to Acetaminophen Instability
FDA Recall date: November 17, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kinderfarms-llc-voluntarily-recalling-all-kindermed-pain-fever-products-due-acetaminophen