The Recall Desk
ModerateFDA (Drugs)·D-0912-2023·Announced 2023-07-19

OTC Allergy Relief Tablets Recalled for Failed Manufacturing Specifications

Topcare Allergy Relief 180 mg tablets recalled for failed impurity and degradation specifications. The recall affects 44,280 cartons distributed nationwide.

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: FDA Class II recall with no reported illnesses or injuries. This is a manufacturing quality control failure addressed through precautionary recall; the absence of reported adverse events and unspecified impurity details place this in the Moderate category.

Plain-English summary

Topcare Allergy Relief 180 mg fexofenadine hydrochloride tablets are being recalled due to failed manufacturing specifications for impurities and product degradation. The product is manufactured by L. Perrigo Company and distributed by Topco Associates LLC.

The recall affects 44,280 cartons distributed nationwide. Specific lot numbers include 2FV1948, 2ER0285, 2ER0411, 2CR0653, and 2GR0331, with varying expiration dates from December 2023 through April 2024.

Consumers who have purchased this medication should discontinue use and contact their healthcare provider or pharmacist with questions. Check medicine cabinets for the affected lot numbers and expiration dates.

The recalled product

Product
TOPCARE ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE)
Brand
TOPCARE ALLERGY RELIEF
Manufacturer
L. Perrigo Company
Category
Drug — Over-the-Counter Antihistamine
Hazard
Affected units
44,280

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 #: a) 2FV1948
  • 2ER0285
  • 2ER0411
  • Exp. Date 01/24 b)2CR0653
  • Exp. Date 12/23 c)2GR0331
  • Exp. Date 04/24

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by L. Perrigo Company 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 13 products in this recall →

Related recalls

Same manufacturer · L. Perrigo Company

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Same hazard · impurity

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