Parents Choice Infant Acetaminophen Recalled for Contaminated Excipient
Perrigo Company is recalling approximately 55,656 bottles of Parents Choice Infants Pain and Fever (Acetaminophen) oral suspension nationwide due to CGMP deviations. The product was manufactured with a contaminated excipient that was recalled from the supplier.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source identifies this as an FDA Class II recall involving a CGMP deviation with a contaminated excipient. The source text does not report any illnesses, injuries, or confirmed harm, and the hazard is related to a manufacturing practice deviation rather than a known high-risk pathogen. This fits the criteria for Moderate severity as a precautionary or quality-related recall.
Plain-English summary
Perrigo Company PLC is recalling approximately 55,656 bottles of Parents Choice Infants Pain and Fever (Acetaminophen) Dye Free Grape Oral Suspension (160mg/5ml, 2 FL OZ per bottle) distributed by Wal-Mart Stores, Inc. nationwide. The affected batch is 1CK1274 with expiration date 02/28/2023 (NDC: 49035-766-16).
The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The products were manufactured using a contaminated excipient that was itself recalled by the excipient supplier.
Consumers who have purchased this product should stop using it. Patients with questions about this recall or the safety of their medication should contact their healthcare provider or pharmacist.
The recalled product
- Product
- PARENTS CHOICE INFANTS PAIN AND FEVER (ACETAMINOPHEN)
- Brand
- PARENTS CHOICE INFANTS PAIN AND FEVER
- Manufacturer
- Perrigo Company PLC
- Affected units
- 55,656
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 (2)
- Batch: 1CK1274
- Exp 02/28/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Perrigo Company PLC 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.
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