The Recall Desk
ModerateFDA (Drugs)·D-0583-2022·Announced 2022-03-02

Acetaminophen Child Strawberry Suspension Recalled for Contaminated Excipient

Perrigo Company PLC is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml) due to use of a contaminated excipient. The product was manufactured with a recalled ingredient from the excipient 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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard stems from a manufacturing deviation involving a contaminated excipient, which represents a quality/purity issue rather than a known high-risk pathogen or serious injury threat. This fits the Moderate category for manufacturing-related quality recalls without reported harm.

Plain-English summary

Perrigo Company PLC is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) bottles, NDC 0363-0971-26, distributed by Walgreen Co. A total of 14,064 bottles have been recalled nationwide.

The recall was initiated because the product was manufactured with a contaminated excipient that had been recalled by the excipient supplier. This represents a deviation from current Good Manufacturing Practice (CGMP) standards.

The affected batches are 1DK0917, 1GK0905, with expiration date 01/31/2023. Consumers who have purchased this product should stop use and consult with a healthcare provider if they have questions about their use of the recalled product.

The recalled product

Product
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0971-26
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 (3)

  • Batch: 1DK0917
  • 1GK0905
  • Exp 01/31/2023

Distribution

Distributed nationwide across the United States.