The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0601-2022·Announced 2022-03-02

UP AND UP Childrens Acetaminophen Recall Due to Contaminated Excipient

Perrigo Company is recalling UP AND UP Childrens Acetaminophen oral suspension due to contamination from a recalled excipient used in manufacturing. The product was 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 CGMP deviation (contaminated excipient). The source text does not report any illnesses, injuries, or hospitalizations. The recall is precautionary based on the manufacturing deviation, making it a moderate-severity voluntary precautionary recall.

Plain-English summary

Perrigo Company PLC is recalling UP AND UP Childrens Acetaminophen (Acetaminophen Child Bubble Gum Flavored Oral Suspension, 160 mg/5 ml, 4 FL OZ per bottle) distributed under the NDC 11673-105-26. The recall affects batch 1CK0998 with expiration date 01/31/2023, totaling 4,992 bottles.

The recall was initiated because the product was manufactured using a contaminated excipient that had been recalled by the excipient supplier. This represents a deviation from good manufacturing practices (CGMP).

The affected product was distributed nationwide in the USA. Consumers who have purchased this product should discontinue use and consult their healthcare provider if they have any concerns.

The recalled product

Product
UP AND UP CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN)
Brand
UP AND UP CHILDRENS ACETAMINOPHEN
Manufacturer
Perrigo Company PLC
Category
Drug — Over-the-Counter Oral Suspension
Hazard
Affected units
4,992

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: 1CK0998
  • 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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