The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0582-2022·Announced 2022-03-02

Children's Cherry Acetaminophen Oral Suspension Recalled for Contaminated Excipient

Perrigo is recalling Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml) because the product was manufactured with a contaminated excipient that was recalled from the 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 with no reported illnesses or injuries documented in the source text. The hazard is manufacturing contamination of an excipient, which presents a theoretical risk but falls under precautionary/CGMP-deviation recalls typical of Class II drug recalls without confirmed harm.

Plain-English summary

Perrigo Company PLC is recalling Children's Cherry Flavored Acetaminophen Oral Suspension, 4 FL OZ (118 mL) bottles (NDC: 45802-203-26), Batch 1GK0903, with expiration date 01/31/2023. The recall affects approximately 4,176 bottles distributed nationwide in the USA.

The product was manufactured with a contaminated excipient that was recalled from the excipient supplier. This represents a deviation from Current Good Manufacturing Practice (CGMP) requirements.

Consumers who have this product should stop using it. For more information or to report an adverse event, contact the FDA or the recalling firm.

The recalled product

Product
Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 45802-203-26
Manufacturer
Perrigo Company PLC
Category
Drug — Oral Suspension / Pediatric
Hazard
Affected units
4,176

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: 1GK0903
  • 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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