The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0599-2022·Announced 2022-03-02

Equate Children's Pain and Fever recalled due to contaminated excipient

Perrigo Company is recalling Equate Children's Pain and Fever (Acetaminophen) oral suspension nationwide due to manufacturing deviations involving contaminated excipient from a 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: This is an FDA Class II recall involving a manufacturing deviation with contaminated excipient. The source text does not report any illnesses or injuries, and the hazard is precautionary in nature. Per the rubric, Class II recalls without reported hospitalization or injury typically score at 2 (Moderate).

Plain-English summary

Perrigo Company PLC is recalling Equate Children's Pain and Fever (Acetaminophen), a bubble gum flavored oral suspension containing 160 mg/5 ml, distributed by Walmart Inc. The recall affects 83,760 packs nationwide.

The recall was issued because the products were manufactured with a contaminated excipient that had been recalled from the excipient supplier. This constitutes a CGMP (Current Good Manufacturing Practices) deviation.

Affected batches include: Batch 1BK0794 with expiration date 12/31/2022, and Batch 1BK1035 with expiration date 01/31/2023. The product is identified by NDC 49035-313-26.

Consumers who have purchased this product should stop using it and contact Perrigo or the retailer for instructions on return or disposal.

The recalled product

Product
EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
Brand
EQUATE CHILDRENS PAIN AND FEVER
Manufacturer
Perrigo Company PLC
Category
Drug — OTC Children's Pain Relief
Hazard
Affected units
83,760

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 (4)

  • Batch: 1BK0794
  • Exp 12/31/2022
  • 1BK1035
  • 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.

See all 51 products in this recall →

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