The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0602-2022·Announced 2022-03-02

Good Sense Children's Pain and Fever acetaminophen oral suspension recall

Perrigo is recalling Good Sense Children's Pain and Fever acetaminophen oral suspension (160 mg/5 ml) in 4 FL OZ bottles due to contaminated excipient used during manufacturing. The recalled batch 1CK0963 (expiration 12/31/2022) was distributed nationwide.

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. No illnesses or injuries are reported in the source text. The hazard is manufacturing deviation with a contaminated excipient, which constitutes a precautionary recall. Per the rubric, Class II recalls without reported harm typically score 2.

Plain-English summary

Perrigo Company PLC is recalling Good Sense Children's Pain and Fever acetaminophen oral suspension, bubble gum flavored, 160 mg/5 ml in 4 FL OZ (118 mL) bottles. The product was manufactured using a contaminated excipient that was itself recalled by the excipient supplier.

The recalled product was distributed nationwide across the United States. Affected consumers should stop use and discard the product if they have the batch code 1CK0963 with expiration date 12/31/2022 (NDC 0113-0020-26).

Consumers with questions or who believe they have used this product should contact their healthcare provider. Reports of adverse events related to this recall can be reported to the FDA's MedWatch program.

The recalled product

Product
GOOD SENSE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
Brand
GOOD SENSE CHILDRENS PAIN AND FEVER
Manufacturer
Perrigo Company PLC
Category
Drug — Pediatric OTC Pain and Fever Relief
Hazard
Affected units
3,024

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: 1CK0963
  • Exp 12/31/2022

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 →

Related recalls

Same manufacturer · Perrigo Company PLC

See all →

Same hazard · contaminated excipient

See all →

Similar recalls