The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0593-2022·Announced 2022-03-02

Acetaminophen Child Strawberry Oral Suspension Recalled for Contaminated Excipient

Perrigo Company PLC is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml) nationwide due to manufacturing with a contaminated excipient that was itself recalled by 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 CGMP deviation with use of a contaminated excipient. No illnesses or injuries are reported in the source text, and the nature of the contamination is not specified. The recall is precautionary rather than responsive to documented harm.

Plain-English summary

Perrigo Company PLC is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) bottles with NDC 37808-759-26, distributed nationwide in the USA.

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

The affected batch is 1GK0905 with an expiration date of 01/31/2023. Consumers who have this product should discontinue use and consult with their healthcare provider or pharmacist regarding appropriate alternatives.

The recalled product

Product
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204. NDC: 37808-759-26
Manufacturer
Perrigo Company PLC
Category
Drug — Oral Suspension
Hazard
Affected units
3,840

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 (2)

  • Batch: 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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