Children's Acetaminophen Suspension Recalled for Manufacturing Defect
Perrigo Company is recalling Children's Pain and Fever (Acetaminophen) oral suspension due to use of contaminated excipient during manufacturing. The product was distributed nationwide in the United States.
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 2/5 (Moderate).
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 FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or deaths, and the hazard described—use of contaminated excipient—is a manufacturing deviation. No specific illness or injury risk is detailed in the source, making this a precautionary recall consistent with Moderate severity.
Plain-English summary
Perrigo Company PLC is recalling Children's Pain and Fever (Acetaminophen) Dye Free Cherry Flavor Oral Suspension, 160mg/5ml, 4 FL OZ (118 mL) bottles nationwide in the United States. The product carries NDC 30142-818-26 and batch 1BK1045 with expiration date 12/31/2022. A total of 3,120 bottles were distributed.
The recall was issued because the products were manufactured with a contaminated excipient that had been recalled from the excipient supplier. This represents a deviation from current Good Manufacturing Practice (CGMP) standards.
Consumers who have purchased this product should stop use and consult with a healthcare provider if they have any questions or concerns about its safety or use.
The recalled product
- Product
- CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
- Brand
- CHILDRENS PAIN AND FEVER
- Manufacturer
- Perrigo Company PLC
- Affected units
- 3,120
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: 1BK1045
- Exp 12/31/2022
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.
See all 51 products in this recall →Related recalls
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