Agency classClass IIOur severity:Moderate FDA (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.

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, 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.
Category: Drug — OTC Pediatric
Hazard: mis-labeling
dosing-error
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 →

Same manufacturer · L. Perrigo Co.

See all →

Moderate
L. Perrigo Recalls Infants' Acetaminophen Due to Unmarked Dosing Syringes
FDA (Drugs) · 2013-11-27
Moderate
L. Perrigo Recalls Infants' Pain and Fever Acetaminophen Due to Dosing Syringe Defect
FDA (Drugs) · 2013-11-27
Moderate
L. Perrigo Recalls Infants' Acetaminophen Suspension Due to Dosing Syringe Markings
FDA (Drugs) · 2013-11-27
Low
Liothyronine Sodium Tablets Recalled for Failed Stability Testing
FDA (Drugs) · 2013-05-15
Low
L. Perrigo Recalls Subpotent PE Daytime Cold/Flu LiqGel Blister Packs
FDA (Drugs) · 2013-04-03

Same hazard · mis labeling