The Recall Desk
ModerateFDA (Drugs)·D-0580-2022·Announced 2022-03-02

Equate Children's Pain and Fever Acetaminophen Suspension Recall

Perrigo Company is recalling Equate Children's Pain and Fever Acetaminophen Suspension (160mg/5ml) due to contaminated excipient used in manufacturing. Approximately 117,552 bottles distributed nationwide are affected.

What this means for you

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 for a manufacturing deviation (contaminated excipient). The source text does not report any illnesses, injuries, or hospitalizations. The recall is precautionary in nature due to a manufacturing process deviation, which falls under the Moderate category for non-urgent quality issues.

Plain-English summary

Perrigo Company PLC is recalling Equate Children's Pain and Fever (Acetaminophen) Suspension, a bubblegum-flavored children's pain and fever reliever. The product was manufactured with a contaminated excipient (inactive ingredient) that had been recalled from the supplier.

The affected product is a 4 fl oz (118 mL) bottle containing 160mg/5ml acetaminophen suspension distributed by Walmart Stores, Inc. Approximately 117,552 bottles were distributed nationwide. The recalled batches are: 1BK0784 (expiration 12/31/2022), 1CK0997 (expiration 01/31/2023), and 1CK1083 (expiration 01/31/2023). The NDC number is 49035-313-26.

Consumers who have purchased this product should stop using it and contact their healthcare provider if they or their child have taken the medication. Consumers may also contact Perrigo Company or return the product to the place of purchase for a full refund.

The recalled product

Product
EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
Brand
EQUATE CHILDRENS PAIN AND FEVER
Manufacturer
Perrigo Company PLC
Hazard
  • contaminated-excipient
  • manufacturing-deviation

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 (5)

  • Batch: 1BK0784
  • Exp 12/31/2022
  • 1CK0997
  • 1CK1083
  • Exp 01/31/2023

Distribution

Distributed nationwide across the United States.

Same brand · EQUATE CHILDRENS PAIN AND FEVER