The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0595-2022·Announced 2022-03-02

Infants Pain and Fever Acetaminophen recalled for contaminated excipient

Perrigo Company is recalling Infants Pain and Fever Acetaminophen Infant Dye Free Grape Oral Suspension due to contaminated excipient used in manufacturing. The recall affects 1,296 bottles 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 deviation (contaminated excipient). The source text does not report any illnesses, injuries, or deaths. The hazard is based on a manufacturing process defect rather than confirmed product contamination or harm.

Plain-English summary

Perrigo Company PLC is recalling Infants Pain and Fever Acetaminophen Infant Dye Free Grape Oral Suspension, 160mg/5ml, 2 FL OZ (59 mL) bottles (NDC: 30142-766-16) distributed by The Kroger Co. The recall involves 1,296 bottles nationwide due to current good manufacturing practice (CGMP) deviations during manufacturing. The product was manufactured using a contaminated excipient that had been recalled from the excipient supplier. Consumers who have purchased this product should stop using it and consult a healthcare provider if they have questions or concerns.

The recalled product

Product
INFANTS PAIN AND FEVER (ACETAMINOPHEN)
Brand
INFANTS PAIN AND FEVER
Manufacturer
Perrigo Company PLC
Category
Drug — Pediatric Oral Suspension
Hazard
Affected units
1,296

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: 1CK1274
  • Exp 02/28/2023

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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