The Recall Desk
ModerateFDA (Drugs)·D-0343-2022·Announced 2022-01-12

Meijer Fexofenadine Hydrochloride Allergy Relief Tablets Recalled

Meijer allergy relief tablets containing fexofenadine hydrochloride are being recalled nationwide due to out-of-specification impurity results found during stability testing.

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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves out-of-specification impurities detected during stability testing, which represents a precautionary quality issue rather than an acute safety threat with documented harm.

Plain-English summary

Perrigo Company PLC is recalling Meijer allergy relief fexofenadine hydrochloride 24HR 180mg antihistamine tablets distributed nationwide in the United States. The recall affects three bottle sizes: 15-count (NDC 41250-060-22, UPC 760236187165), 30-count (NDC 41250-060-39, UPC 760236187172), and 45-count (NDC 41250-060-95, UPC 760236187325) bottles. A total of 4,536 containers are affected.

The recall was initiated because stability testing revealed an out-of-specification result for impurity A. The affected lot numbers are: 0HE2530 (expiration 12/31/2021) and 0KE2430 (expiration 2/28/2022) for 15-count bottles; 0LR0362 (expiration 6/30/2022) and 1BR0462 (expiration 10/31/2022) for 30-count bottles; and 0FR0460 (expiration 2/28/2022) for 45-count bottles. The product was manufactured in the Czech Republic and distributed by Meijer Distribution Inc, Grand Rapids, Michigan.

Consumers who have purchased this product should stop using it and contact Meijer or Perrigo Company PLC with questions.

The recalled product

Product
Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 41250-060-22 UPC 7 60236 18716 5; b) 30 count bottle, NDC 41250-060-39, UPC 7 60236 18717 2; c) 45 count bottle, NDC 41250-060-95, UPC 7 60236 18732 5; Made
Manufacturer
Perrigo Company PLC
Category
Drug — Antihistamine / Allergy Relief
Hazard
  • impurity-degradation
  • out-of-specification

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 (8)

  • Lot a) 0HE2530
  • Exp 12/31/2021
  • 0KE2430
  • Exp 2/28/2022 b) 0LR0362
  • Exp 6/30/2022
  • 1BR0462
  • Exp 10/31/2022 c) 0FR0460
  • Exp 2/28/2022

Distribution

Distributed nationwide across the United States.

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