The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0597-2022·Announced 2022-03-02

Parents Choice Infant Acetaminophen Recalled for Contaminated Excipient

Perrigo Company is recalling approximately 55,656 bottles of Parents Choice Infants Pain and Fever (Acetaminophen) oral suspension nationwide due to CGMP deviations. 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: The source identifies this as an FDA Class II recall involving a CGMP deviation with a contaminated excipient. The source text does not report any illnesses, injuries, or confirmed harm, and the hazard is related to a manufacturing practice deviation rather than a known high-risk pathogen. This fits the criteria for Moderate severity as a precautionary or quality-related recall.

Plain-English summary

Perrigo Company PLC is recalling approximately 55,656 bottles of Parents Choice Infants Pain and Fever (Acetaminophen) Dye Free Grape Oral Suspension (160mg/5ml, 2 FL OZ per bottle) distributed by Wal-Mart Stores, Inc. nationwide. The affected batch is 1CK1274 with expiration date 02/28/2023 (NDC: 49035-766-16).

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The products were manufactured using a contaminated excipient that was itself recalled by the excipient supplier.

Consumers who have purchased this product should stop using it. Patients with questions about this recall or the safety of their medication should contact their healthcare provider or pharmacist.

The recalled product

Product
PARENTS CHOICE INFANTS PAIN AND FEVER (ACETAMINOPHEN)
Brand
PARENTS CHOICE INFANTS PAIN AND FEVER
Manufacturer
Perrigo Company PLC
Category
Drug — Over-the-Counter Pain/Fever Relief
Hazard
Affected units
55,656

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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