The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0341-2022·Announced 2022-01-12

Kroger Allergy Relief Fexofenadine Tablets Recalled for Impurity

Perrigo Company is recalling Kroger Allergy Relief Fexofenadine Hydrochloride 60mg tablets due to an out-of-specification impurity detected during stability testing.

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 involving a pharmaceutical product with an out-of-specification impurity. No hospitalizations, illnesses, or injuries are reported in the source text. The recall is precautionary based on a stability testing failure, making it a moderate-severity situation.

Plain-English summary

Perrigo Company PLC is recalling Kroger Allergy Relief Fexofenadine Hydrochloride 12HR 60mg antihistamine tablets, 12 count bottles, distributed nationwide in the United States. 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 affected product was distributed by Kroger CO., Cincinnati, Ohio. The recalled lots are 0LE2178 (expiration 1/31/2022) and 0ME2516 (expiration 4/30/2022), with NDC 30142-555-53 and UPC 0 41260 35588 2. Approximately 48,816 containers are subject to this recall.

Consumers with this product should stop using it. Those with questions about the recall should contact their pharmacy or healthcare provider.

The recalled product

Product
Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2
Manufacturer
Perrigo Company PLC
Category
Drug — Antihistamine Tablet
Hazard
Affected units
48,816

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 0LE2178
  • Exp 1/31/2022
  • 0ME2516
  • Exp 4/30/2022

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 →

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