The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-004-2014·Announced 2013-11-27

L. Perrigo Recalls Infants' Pain and Fever Acetaminophen Due to Dosing Syringe Defect

L. Perrigo is recalling 35,136 bottles of Infants' Pain and Fever acetaminophen because the included oral dosing syringes may lack dose markings.

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 recall is classified as FDA Class II and involves a packaging defect (missing dose markings) that creates a remote potential for incorrect dosing, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

L. Perrigo Co. is voluntarily recalling 35,136 bottles of Infants' Pain and Fever acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor. The product is sold in 2 FL OZ (59 mL) bottles co-packaged with an oral dosing syringe in a carton. The recall is being conducted because there is a remote potential that some cartons were packaged with an oral dosing syringe that lacks dose markings.

The affected product is distributed nationwide under several brand names, including Leader, Walgreens, Kroger, H-E-B, Babies R Us, Healthy Accents, and Health Mart Pharmacy. The specific lot numbers involved are 3HK0671 (Exp 06/15), 3JK0610 (Exp 07/15), and 3KK0606 (Exp 08/15). Consumers should check their cartons for these lot numbers and expiration dates.

Consumers who have purchased this product should stop using the included syringe if it lacks dose markings and consult a healthcare professional for proper dosing instructions. The recall is classified as FDA Class II, indicating a remote but possible risk of harm due to the potential for incorrect dosing.

The recalled product

Product
PAIN AND FEVER (ACETAMINOPHEN)
Brand
PAIN AND FEVER
Manufacturer
L. Perrigo Co.
Category
Drug — OTC Pediatric
Hazard
Affected units
35,136

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 (6)

  • Lot #: 3HK0671
  • Exp 06/15
  • 3JK0610
  • Exp 07/15
  • 3KK0606
  • Exp 08/15

UPCs (7)

  • 096295120950
  • 311917132211
  • 041260358319
  • 041220880669
  • 717851200946
  • 725439958141
  • 052569132487

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 →

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