Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0345-2022·Announced 2022-01-12

Perrigo Fexofenadine Hydrochloride 180mg tablets recalled for impurity

Perrigo Company PLC is recalling Fexofenadine Hydrochloride 180mg antihistamine tablets due to an out-of-specification impurity result detected during stability testing. The recall affects approximately 89,664 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 involving failed impurity specifications without any reported illnesses or injuries. The source text indicates a quality control failure detected through testing rather than a harm event, making this a precautionary recall that meets the Moderate severity threshold.

Plain-English summary

Perrigo Company PLC is recalling Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine in 100-count bottles (NDC 45802-571-78, UPC 3 45802 571 78 6) due to failed impurities and degradation specifications. During stability testing, an out-of-specification result was obtained for impurity A.

The affected product was made in the Czech Republic and distributed by Perrigo in Allergan, Michigan. Approximately 89,664 containers have been distributed nationwide in the USA across multiple lots: Lot 0FR0563 (Exp 02/28/22), 0GR0530 (Exp 03/31/22), and lots 0KR0434, 0KR0435, 0LR0366, 0LR0367, and 0LR0368 (Exp 06/30/22).

Consumers who have purchased this product should stop using it and consult their healthcare provider or pharmacist about alternative treatment options.

The recalled product

Product: Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6
Manufacturer: Perrigo Company PLC
Category: Drug — Antihistamine Tablet
Hazard: impurity-degradation
out-of-spec-quality
Affected units: 89,664

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 (10)

Lot 0FR0563
Exp 02/28/22
0GR0530
Exp 03/31/22
0KR0434
0KR0435
0LR0366
0LR0367
0LR0368
Exp 06/30/22.

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

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Same hazard · impurity degradation