The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0588-2022·Announced 2022-03-02

Children's Acetaminophen Oral Suspension Recall due to Contaminated Excipient

Perrigo Company is recalling Children's Pain and Fever (Acetaminophen) Oral Suspension distributed by Kroger nationwide due to manufacturing with a contaminated excipient. The product was made with an ingredient sourced from a supplier that had recalled that same excipient.

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, and the source text describes a contaminated excipient but does not report any illnesses, injuries, or specify the nature of the contamination. Under the rubric, FDA Class II without hospitalization or illness reports, combined with a manufacturing/quality defect, typically falls into the Moderate category.

Plain-English summary

Perrigo Company PLC is recalling Children's Pain and Fever (Acetaminophen) Dye Free Cherry Flavor Oral Suspension in 4 FL OZ (118 mL) bottles. This product was distributed by The Kroger Co. nationwide in the United States. The recall was initiated because the product was manufactured using a contaminated excipient—an inactive ingredient—that had been recalled by the supplier.

The affected product is identified by NDC 30142-818-26, Batch 1BK1045, with expiration date 12/31/2022. Approximately 20,448 bottles of this product were distributed.

Consumers in possession of this medication should discontinue use. The source material provided does not specify what contamination is present in the excipient or what health risks may result. Consumers with questions are advised to contact their healthcare provider or pharmacist.

The recalled product

Product
CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
Brand
CHILDRENS PAIN AND FEVER
Manufacturer
Perrigo Company PLC
Category
Drug — Oral Suspension / Pediatric
Hazard
Affected units
20,448

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 →

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