The Recall Desk
ModerateFDA (Drugs)·D-0585-2022·Announced 2022-03-02

CVS Infant's Grape Acetaminophen Suspension Recalled for Contaminated Excipient

CVS Pharmacy is recalling Infant's Grape Flavored Acetaminophen Oral Suspension nationwide because the product was manufactured with a contaminated excipient that was recalled from its supplier.

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: The FDA classified this as a Class II recall, and the source text describes a CGMP (Current Good Manufacturing Practice) deviation involving a contaminated excipient. The source text does not report any illnesses or injuries, making this a manufacturing or precautionary recall. Per the rubric, this qualifies as Moderate.

Plain-English summary

CVS Pharmacy, Inc. is recalling Infant's Grape Flavored Acetaminophen Oral Suspension, 160mg/5ml, 2 FL OZ (59 mL) bottles distributed nationwide. The product was manufactured by Perrigo Company PLC. According to the FDA, the recall was initiated because the product was manufactured with a contaminated excipient that had been recalled from the excipient supplier.

Affected batches are 1CK1276, 1FK1184, 1GK0821, and 1EK1046, with expiration date 02/28/2023. The NDC number is 59779-946-16. A total of 37,152 bottles were distributed.

Consumers who have purchased this product should stop using it and consult their healthcare provider or pharmacist for guidance. For more information, consumers can contact CVS Pharmacy, Inc. at One CVS Drive, Woonsocket, RI 02895.

The recalled product

Product
Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC: 59779-946-16
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)

  • Batch: 1CK1276
  • 1FK1184
  • 1GK0821 and 1EK1046
  • Exp 02/28/2023

Distribution

Distributed nationwide across the United States.