The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0587-2022·Announced 2022-03-02

Good Sense Acetaminophen Child Suspension Recalled Due to Contaminated Excipient

Perrigo is recalling Good Sense Pain and Fever acetaminophen child oral suspension (160mg/5ml, 4 FL OZ bottles) nationwide because the product was manufactured with a contaminated excipient that was recalled by 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: The FDA classified this as Class II. The source text does not report any illnesses, injuries, or deaths associated with the contaminated excipient, and the hazard is a manufacturing deviation without explicit identification of a specific harmful substance. This meets the threshold for Moderate severity.

Plain-English summary

Perrigo Company PLC is recalling Good Sense Pain and Fever Acetaminophen Child Dye Free Cherry Flavor Oral Suspension, 160mg/5ml, 4 FL OZ (118 mL) bottles, NDC 0113-8959-26. The recall affects 2,832 bottles with batch number 1BK1045 and expiration date 12/31/2022.

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

The recalled product was distributed nationwide in the USA. Consumers who have purchased this product should stop use and contact Perrigo Company PLC with questions or concerns.

The recalled product

Product
GOOD SENSE PAIN AND FEVER (ACETAMINOPHEN)
Brand
GOOD SENSE PAIN AND FEVER
Manufacturer
Perrigo Company PLC
Category
Drug — Oral Suspension / OTC Pediatric
Hazard
Affected units
2,832

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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