The Recall Desk
ModerateFDA (Drugs)·D-003-2014·Announced 2013-11-27

L. Perrigo Recalls Infants' Acetaminophen Suspension Due to Dosing Syringe Markings

L. Perrigo Co. is recalling 143,892 bottles of infants' acetaminophen suspension because some may be packaged with dosing syringes lacking 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 FDA classifies this as a Class II recall. The hazard involves a potential dosing error due to missing markings on the syringe, which is a significant but remote risk without reported injuries.

Plain-English summary

L. Perrigo Co. is recalling 143,892 bottles of Pain and Fever (Acetaminophen) suspension liquid, 160 mg/5 mL, dye-free cherry flavor. The product is co-packaged with an oral dosing syringe and was distributed nationwide under various store brands, including Equaling, Up & Up, Equate, Meijer, Walgreens, Kroger, Publix, CareOne, and Harmon FaceValues.

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 include 2 FL OZ bottles with lot numbers 3HK0564, 3HK0672, 3JK0594, 3JK0595, and 3KK0815, and 4 FL OZ bottles with lot number 3GK0645.

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 or retailer for a refund or replacement. The FDA classifies this as a Class II recall.

The recalled product

Product
PAIN AND FEVER (ACETAMINOPHEN)
Brand
PAIN AND FEVER
Manufacturer
L. Perrigo Co.
Category
Drug — OTC Pediatric
Hazard
Affected units
143,892

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 (9)

  • 2 FL OZ Lot #: 3HK0564
  • Exp 06/15
  • 3HK0672
  • 3JK0594
  • Exp 07/15
  • 3JK0595
  • Exp 08/15
  • 3KK0815
  • 4 FL OZ Lot #: 3GK0645

UPCs (10)

  • 041163486577
  • 370030625291
  • 681131001854
  • 713733313766
  • 311917132228
  • 041260367380
  • 041260358296
  • 041415395732
  • 341520310065
  • 370030510184

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 →

Related recalls

Same brand · PAIN AND FEVER

Same manufacturer · L. Perrigo Co.

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Same hazard · dosing error

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