The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0596-2022·Announced 2022-03-02

Infants Pain and Fever acetaminophen recalled for contaminated excipient

Perrigo Company is recalling Infants Pain and Fever acetaminophen oral suspension (160mg/5ml) distributed nationwide due to contamination from a recalled excipient supplier. The product was manufactured with a contaminated ingredient that does not meet manufacturing standards.

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 of an over-the-counter drug. The source text indicates a manufacturing deviation related to a contaminated excipient from a recalled supplier, but does not report any illnesses, injuries, or hospitalizations. This is a precautionary recall based on manufacturing compliance issues.

Plain-English summary

Perrigo Company PLC is recalling Infants Pain and Fever acetaminophen dye-free grape oral suspension, 160mg/5ml, in 2 FL OZ (59 mL) bottles distributed nationwide. The recall involves batch 1CK1274 with an expiration date of 02/28/2023 (NDC: 30142-766-16). A total of 5,184 bottles are affected.

The recall was initiated because the products were manufactured using a contaminated excipient (inactive ingredient) that had itself been recalled by the supplier. This represents a deviation from Current Good Manufacturing Practice (CGMP) requirements.

Consumers who have purchased this product should stop use and consult with a healthcare provider or pharmacist regarding safe pain and fever relief alternatives for infants. The product batch, expiration date, and NDC number are provided above to assist in identification.

The recalled product

Product
INFANTS PAIN AND FEVER (ACETAMINOPHEN)
Brand
INFANTS PAIN AND FEVER
Manufacturer
Perrigo Company PLC
Category
Drug — Over-the-Counter Pain and Fever Relief
Hazard
Affected units
5,184

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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