UP AND UP Acetaminophen Infant Suspension Recalled for Contaminated Excipient
Perrigo Company PLC is recalling UP AND UP Acetaminophen Infant Dye Free Grape Oral Suspension due to use of a contaminated excipient supplied by an outside vendor. The product was distributed nationwide.
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: This is an FDA Class II recall with no reported illnesses or injuries. The recall is based on manufacturing process deviations (CGMP non-compliance) and use of a contaminated ingredient, which constitutes a quality/safety concern but without evidence of actual harm. This meets the threshold for Moderate severity.
Plain-English summary
UP AND UP Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5mL), distributed by Target Corporation, is being recalled by manufacturer Perrigo Company PLC due to Current Good Manufacturing Practice (CGMP) deviations.
The products were manufactured using a contaminated excipient that had itself been recalled by the supplier. The affected batch is 1CK0907 with an expiration date of 01/31/2023, with a total of 22,140 bottles affected.
The product was distributed nationwide in the USA. Consumers who have purchased this product should stop using it and consult with their pharmacist or healthcare provider with any questions or concerns.
The recalled product
- Product
- UP AND UP ACETAMINOPHEN (ACETAMINOPHEN)
- Brand
- UP AND UP ACETAMINOPHEN
- Manufacturer
- Perrigo Company PLC
- Affected units
- 22,140
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: 1CK0907
- Exp 01/31/2023
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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