Acetaminophen Oral Suspension Recalled for Contaminated Excipient
Perrigo is recalling Acetaminophen Oral Suspension Grape Flavor (160 mg/5 mL, 16 fl oz bottles) nationwide because the product was manufactured with a contaminated excipient that was recalled by the excipient 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 FDA classified this as a Class II recall. The source text identifies a CGMP deviation involving a contaminated excipient but does not report any illnesses, injuries, or deaths. This is a manufacturing quality control issue with a precautionary basis.
Plain-English summary
Perrigo Company PLC is recalling Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) bottles distributed nationwide in the United States. The recall was initiated because the product was manufactured with a contaminated excipient that had been recalled from the excipient supplier, representing a deviation from Current Good Manufacturing Practice (CGMP) standards.
Affected bottles have NDC 50941-009-43, Batch 1AK1031, with an expiration date of 12/31/2022. A total of 14,868 bottles were distributed.
Consumers who have this product should discontinue use. For questions or to report adverse events, consumers should contact Perrigo or consult their healthcare provider.
The recalled product
- Product
- Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 50941-009-43
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Oral Suspension
- Affected units
- 14,868
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: 1AK1031
- 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.
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