The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0594-2022·Announced 2022-03-02

Acetaminophen Child Strawberry Oral Suspension Recalled for Contaminated Excipient

Target-distributed Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml) is being recalled because it was manufactured with a contaminated excipient that was itself recalled from the supplier.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 involving a manufacturing deviation (use of contaminated excipient). The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is manufacturing-process-related rather than a known direct safety threat. Per the rubric, Class II recalls without reported illness are typically scored as 2 (Moderate).

Plain-English summary

Perrigo Company PLC is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) bottles distributed by Target Corporation nationwide. The product has NDC 11673-759-26 and affected batch codes are 1FK1252, 1GK0905, with expiration date 01/31/2023.

The recall was initiated because the products were manufactured using a contaminated excipient (an inactive ingredient) that had itself been recalled by the excipient supplier. This represents a deviation from current Good Manufacturing Practice (CGMP) standards.

Consumers who have purchased this product should consult their pharmacist or healthcare provider for guidance. This is a Class II recall.

The recalled product

Product
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-759-26
Manufacturer
Perrigo Company PLC
Category
Drug — Oral Suspension / Pediatric
Hazard
Affected units
14,688

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: 1FK1252
  • 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 →

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