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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 376,370
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.
Part of a larger recall action
This product is one of 2 recalled by KINDER FARMS LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · INFANTS PAIN AND FEVER
- ModerateInfants Pain and Fever Acetaminophen recalled for contaminated excipient
FDA (Drugs) · 2022-03-02
- ModerateInfants Pain and Fever acetaminophen recalled for contaminated excipient
FDA (Drugs) · 2022-03-02
Same manufacturer · KINDER FARMS LLC
See all →- HighChildren's Acetaminophen Suspension Recalled for Failed Impurity Specifications
FDA (Drugs) · 2023-12-13
Same hazard · impurity
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