Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0330-2022·Announced 2022-01-12

Amazon Allergy Fexofenadine Hydrochloride Tablets Recalled for Failed Impurity Specifications

Amazon-branded Allergy Fexofenadine Hydrochloride Tablets 180 mg are being recalled because testing found an out-of-specification impurity 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 of a drug product with a quality defect (out-of-specification impurity) detected during stability testing. No illnesses or injuries have been reported, and the hazard is based on testing results rather than actual patient harm. Per the rubric, Class II recalls without reported hospitalization or injury typically score 2 (Moderate).

Plain-English summary

Amazon Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count bottles are being recalled. The product was manufactured by Perrigo Company PLC in the Czech Republic and distributed by Amazon.com Services LLC nationwide in the USA. Lot #1BR0462 with expiration 10/31/2022 is affected.

The recall was initiated due to failed impurities and degradation specifications. During stability testing, an out-of-specification result was obtained for impurity A, indicating the product did not meet required quality standards.

Consumers in possession of this product should stop use and contact Amazon for instructions on return or disposal. The affected product can be identified by the UPC 3 70030 11466 5 and lot number 1BR0462.

The recalled product

Product: amazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count bottle, Made in the Czech Republic, Distributed by: Amazon.com Services LLC 410 Terry Avenue N. Seattle, WA 98109 UPC 3 70030 11466 5
Manufacturer: Perrigo Company PLC
Category: Drug — Antihistamine
Hazard: impurity-degradation
failed-specifications
Affected units: 32,232

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 # 1BR0462
Exp 10/31/2022

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

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Same hazard · impurity degradation