Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0338-2022·Announced 2022-01-12

Health Mart Fexofenadine Hydrochloride 180mg Tablets Recall

Perrigo Company is recalling Health Mart Fexofenadine Hydrochloride 180mg antihistamine tablets due to failed impurity specifications detected during stability testing. The recall affects approximately 6,960 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: The FDA classified this as Class II. The source text does not report any illnesses, injuries, or hospitalizations—only a failed specification during stability testing. This is a precautionary pharmaceutical recall based on manufacturing standards rather than confirmed patient harm, consistent with a Moderate severity rating.

Plain-English summary

Perrigo Company PLC is recalling Health Mart Fexofenadine Hydrochloride 24HR 180mg antihistamine tablets, 70-count bottles, due to impurity issues. During stability testing, an out-of-specification result was obtained for impurity A, indicating the product failed required purity standards.

The recalled product was distributed nationwide in the USA. The affected lot is 0FR0461 with an expiration date of 2/25/2022. Approximately 6,960 containers are involved in this recall. The product was distributed by McKesson of Irvine, Texas, and manufactured in the Czech Republic.

Consumers who have purchased this product should stop using it. Patients should consult their healthcare provider or pharmacist about obtaining a replacement or alternative antihistamine. The product is identified by NDC 62011-0233-1 and UPC 0 52569 13787 1.

The recalled product

Product: Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0233-1, UPC 0 52569 13787 1
Manufacturer: Perrigo Company PLC
Category: Drug — Antihistamine Tablet
Hazard: impurity-degradation
failed-specification
Affected units: 6,960

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 (2)

Lot 0FR0461
Exp 2/25/2022

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

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Same hazard · impurity degradation