Agency classClass IIOur severity:Moderate FDA (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.

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: 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…
Manufacturer: Perrigo Company PLC
Category: Drug — Antihistamine / Allergy Relief
Hazard: impurity-degradation
out-of-specification
Affected units: 138,144

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.

Part of a larger recall action

This product is one of 30 recalled by Perrigo Company PLC 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 30 products in this recall →

Same manufacturer · Perrigo Company PLC

See all →

Moderate
CareOne Severe Congestion Nasal Spray Recalled Due to Contaminated Excipient
FDA (Drugs) · 2022-03-02
Moderate
Equate Children's Pain and Fever Acetaminophen Suspension Recall
FDA (Drugs) · 2022-03-02
Moderate
Equaline Nasal Oxymetazoline HCl Nasal Spray Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02
Moderate
UP AND UP Childrens Acetaminophen Recall Due to Contaminated Excipient
FDA (Drugs) · 2022-03-02
Moderate
CVS Infant's Grape Acetaminophen Suspension Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02

Same hazard · impurity degradation