The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0589-2022·Announced 2022-03-02

Equate Children's Pain and Fever Acetaminophen Recalled for Contaminated Excipient

Perrigo Company is recalling Equate Children's Pain and Fever acetaminophen suspension due to contamination from a recalled excipient used during manufacturing. The affected batch 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 involving a manufacturing process deviation (contaminated excipient) with no reported illnesses or injuries stated in the source. The source text does not specify the nature of the contamination or a known hazard, making this a precautionary manufacturing-quality recall.

Plain-English summary

Perrigo Company PLC is recalling Equate Children's Pain and Fever (Acetaminophen) dye-free cherry flavor oral suspension in 4 FL OZ (118 mL) bottles. The product was manufactured with a contaminated excipient that was recalled from the excipient supplier, representing a deviation from good manufacturing practices.

The recalled product is acetaminophen 160 mg/5 mL suspension with NDC 49035-959-26, Batch 1BK1045, expiration date 12/31/2022. A total of 30,144 bottles were distributed nationwide in the USA by Walmart Inc.

Consumers should stop using this product. Anyone with questions or who believes they have been harmed should consult their healthcare provider.

The recalled product

Product
EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
Brand
EQUATE CHILDRENS PAIN AND FEVER
Manufacturer
Perrigo Company PLC
Category
Drug — Over-the-Counter Oral Suspension
Hazard
Affected units
30,144

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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