The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0579-2022·Announced 2022-03-02

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.

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 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
Hazard
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.

See all 51 products in this recall →

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