The Recall Desk
ModerateFDA (Drugs)·D-0335-2022·Announced 2022-01-12

CVS Allergy Relief Fexofenadine Tablets Recalled for Impurity

CVS Allergy Relief Fexofenadine Hydrochloride Tablets 60 mg are being recalled because stability testing found an out-of-specification result for impurity A. The recall affects approximately 138,144 containers 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: 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 quality defect rather than an immediate safety threat with documented harm. This meets the criteria for a Moderate severity rating.

Plain-English summary

Perrigo Company PLC is recalling CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg, 12-hour antihistamine. The recall was initiated because an out-of-specification result for impurity A was obtained during stability testing, indicating the product failed impurities and degradation specifications.

The recalled product was distributed nationwide in two package sizes: 12-count bottles (NDC 59779-425-53, UPC 0 50428 25414 1) and 24-count bottles (NDC 59779-425-62, UPC 0 50428 53435 9). The affected lot numbers are 0ME2516 (expiration 4/30/2022), 0ME2515 (expiration 4/30/2022), and 0KE2982 (expiration 1/31/2022). Approximately 138,144 containers are affected.

Consumers who have this product should stop using it and contact CVS Pharmacy for further instructions or replacement. Healthcare providers and pharmacists should also be aware of this recall.

The recalled product

Product
CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC 59779-425-53, UPC 0 50428 25414 1; b)24 count bottle, NDC 59779-425-62, UPC 0 50428 53435 9; Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02
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 (5)

  • Lot # a) 0ME2516
  • Exp 4/30/2022 b)0ME2515
  • Exp 4/30/2022
  • 0KE2982
  • Exp 1/31/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category