The Recall Desk
ModerateFDA (Drugs)·D-005-2014·Announced 2013-11-27

L. Perrigo Recalls Infants' Pain and Fever Due to Unmarked Syringes

L. Perrigo Co. is recalling 27,504 bottles of TopCare Infants' Pain and Fever because some cartons may contain dosing syringes without dose markings.

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: The recall is classified as FDA Class II, but the source describes the hazard as a 'remote potential' for missing markings on a dosing device, which aligns with the rubric for moderate severity involving minor labeling or packaging defects without reported injuries.

Plain-English summary

L. Perrigo Co. is recalling 27,504 bottles of TopCare Infants' Pain and Fever (Acetaminophen) suspension liquid. The product is a 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe. It is sold under multiple brand names, including TopCare, Meijer, Rite Aid, Walgreens, and Kroger, and was distributed nationwide.

The recall is due to a defective delivery system. There is a remote potential that cartons of the product could be co-packaged with an oral dosing syringe that lacks dose markings. The affected lots are 3GK0704 (Exp 04/15), 3JK0597 (Exp 08/15), and 3KK0359 (Exp 08/15).

Consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, consumers should stop using it and contact the manufacturer for a refund or replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN)
Brand
TOPCARE INFANTS PAIN AND FEVER
Manufacturer
L. Perrigo Co.
Affected units
27,504

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 (5)

  • Lot #: 3GK0704
  • Exp 04/15
  • 3JK0597
  • Exp 08/15
  • 3KK0359

UPCs (5)

  • 036800346505
  • 713733314039
  • 011822353410
  • 311917132235
  • 041260358302

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by L. Perrigo Co. 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 4 products in this recall →