The Recall Desk
HighFDA (Drugs)·D-0143-2024·Announced 2023-12-13

KinderFarms Infants' Acetaminophen Recalled for Failed Impurity and Degradation Standards

KinderFarms is recalling approximately 376,370 bottles of Infants' Pain and Fever acetaminophen oral suspension nationwide due to failures in impurity and degradation specifications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for failed impurity and degradation specifications in a pediatric medication. This falls under the rubric category of risk-of-harm products where injury has not yet been reported, despite the absence of illnesses or hospitalizations.

Plain-English summary

KinderFarms LLC is recalling approximately 376,370 bottles of Infants' Pain and Fever acetaminophen oral suspension (160 mg per 5 mL) nationwide. The product is distributed under the brand name KinderMed Infants' Pain & Fever with organic cherry flavor in 2 FL OZ bottles.

The recall was initiated because the product failed to meet established impurity and degradation specifications. The affected lot numbers are: CJ70902 (07/2024), CJ76275 and WJ81412 (08/2024), WK02194, WK02196, WK04141, WK02873, and WK05542 (10/2024), WK02874 and WK04794 (01/2025), and WK04793 and WK06535 (03/2025). The product was distributed nationwide and carries UPC 850001805698 and NDC 82673-096-02.

No illnesses or injuries have been reported in connection with this product. This is a Class II recall initiated by the FDA.

The recalled product

Product
INFANTS PAIN AND FEVER (ACETAMINOPHEN)
Brand
INFANTS PAIN AND FEVER
Manufacturer
KINDER FARMS LLC
Category
Drug
Hazard
  • impurity
  • degradation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • Lot #: CJ70902
  • Exp: 07/2024
  • CJ76275
  • WJ81412
  • Exp: 08/2024
  • WK02194
  • WK02196
  • WK04141
  • WK02873
  • WK05542
  • Exp: 10/2024
  • WK02874
  • WK04794
  • Exp: 01/2025
  • WK04793
  • WK06535
  • Exp: 03/2025.

UPCs (1)

  • 850001805698

Distribution

Distributed nationwide across the United States.

Same brand · INFANTS PAIN AND FEVER