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
Affected units
14,064

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.

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 →

Same hazard · contaminated excipient

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