The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0590-2022·Announced 2022-03-02

DG Health Children's Acetaminophen Recalled for Contaminated Excipient

Perrigo Company is recalling DG Health Children's Pain and Fever (acetaminophen) oral suspension because the product was manufactured with a contaminated excipient that was itself recalled by its 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: The source identifies this as an FDA Class II recall with a CGMP deviation involving a contaminated excipient. No illnesses or injuries are reported in the source text, and the hazard is manufacturing/control-based rather than an acute safety threat. This fits the Moderate category for manufacturing-related concerns without reported harm.

Plain-English summary

Perrigo Company PLC is recalling DG Health Children's Pain and Fever, a grape-flavored acetaminophen oral suspension (160 mg/5 mL) in 4 FL OZ (118 mL) bottles, distributed nationwide by Dolgencorp, LLC. The recall affects 16,992 bottles from batch 1CK1001 with an expiration date of 12/31/2022, identified by NDC 55910-251-26.

The recall was issued because the product was manufactured using a contaminated excipient that had been recalled by its supplier. This represents a manufacturing deviation from current good manufacturing practice (CGMP) standards.

Consumers who have purchased this product should stop use immediately and consult their healthcare provider with questions. The product should be discarded or returned to the place of purchase.

The recalled product

Product
DG HEALTH CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
Brand
DG HEALTH CHILDRENS PAIN AND FEVER
Manufacturer
Perrigo Company PLC
Category
Drug — Over-the-Counter Pain/Fever Relief
Hazard
Affected units
16,992

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: 1CK1001
  • 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