The Recall Desk
ModerateFDA (Drugs)·D-0352-2022·Announced 2022-01-12

Wal-Fex Fexofenadine Hydrochloride Tablets Recalled for Impurity Specification Failure

Perrigo Company PLC is recalling Wal-Fex Fexofenadine Hydrochloride 180mg tablets distributed nationwide because impurity A levels exceeded specifications 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. The source text states only that impurity specifications were not met during stability testing, with no reported illnesses, injuries, or hospitalizations. The hazard is potential rather than actual, making this a precautionary quality-control recall.

Plain-English summary

Perrigo Company PLC is recalling Wal-Fex Fexofenadine Hydrochloride 180mg antihistamine tablets distributed nationwide by Walgreen Co. The recall affects three package sizes: 5-count bottles (NDC 0363-0600-13), 30-count bottles (NDC 0363-0600-39), and 90-count bottles (NDC 0363-0600-75). A total of 14,160 containers were distributed.

The recall was initiated because stability testing revealed that impurity A levels in the tablets were out of specification. The affected lots are: Lot 0JE2406 (expiration 02/28/2022), Lot 0FR0459 (expiration 02/28/2022), and Lot 0KR0465 (expiration 04/30/2022). The product was manufactured in the Czech Republic.

Consumers who have purchased this product should contact their healthcare provider or pharmacist for guidance. Consumers may also report adverse reactions to the FDA via MedWatch or contact Perrigo Company PLC directly.

The recalled product

Product
Wal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, packaged as a) 5 count bottle, NDC 0363-0600-13,UPC 3 11917 12267 0, b)30 count bottle, NDC 0363-0600-39 UPC 3 11917 16172 3 c) 90 count bottle, NDC 0363-0600-75 UPC 3 11917 12271 7 ; Distributed by Walgree
Manufacturer
Perrigo Company PLC
Category
Drug — Antihistamine / Oral Tablet
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 (4)

  • Lot # a)0JE2406
  • Exp 02/28/2022 b) 0FR0459
  • Exp 02/28/2022. c) 0KR0465
  • Exp 04/30/2022

Distribution

Distributed nationwide across the United States.

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