The Recall Desk
ModerateFDA (Drugs)·D-0598-2022·Announced 2022-03-02

Equate Infant Pain and Fever Acetaminophen Recall Due to Contaminated Excipient

Perrigo Company is recalling Equate infant's acetaminophen oral suspension due to manufacturing deviations involving a contaminated excipient from a supplier. The product was distributed nationwide.

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. The source text does not report any illnesses, injuries, or specific safety incidents—only that manufacturing occurred with a contaminated excipient that was itself recalled. The hazard is potential/theoretical rather than confirmed, warranting a Moderate severity classification.

Plain-English summary

Perrigo Company PLC is recalling Equate Pain and Fever (Acetaminophen) Infant's Grape Flavored Oral Suspension, 160mg/5ml, 2 FL OZ bottles. The recall affects approximately 68,688 bottles distributed nationwide in the USA.

The recall was initiated due to contaminated excipient used in manufacturing. The excipient itself was previously recalled from the supplier, indicating a breakdown in quality control during the product manufacturing process.

Affected batches are 1FK1027, 1FK1184, and 1EK1046, with expiration date 02/28/2023. The product was distributed by Wal-Mart Stores, Inc.

Consumers who have purchased this product should stop using it and contact their healthcare provider or poison control for guidance on next steps.

The recalled product

Product
EQUATE PAIN AND FEVER (ACETAMINOPHEN)
Brand
EQUATE PAIN AND FEVER
Manufacturer
Perrigo Company PLC
Hazard
  • contaminated-excipient
  • cgmp-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 (4)

  • Batches: 1FK1027
  • 1FK1184
  • 1EK1046
  • Exp 02/28/2023

Distribution

Distributed nationwide across the United States.

Same brand · EQUATE PAIN AND FEVER