Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0354-2022·Announced 2022-01-12

Amazon Basic+Care Fexofenadine Tablets Recalled for Failed Impurity Specifications

Amazon Basic+Care Allergy Fexofenadine Hydrochloride Tablets (60 mg, 100-count) are being recalled because impurity levels exceeded acceptable limits during stability testing. The recall affects 38,352 bottles 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 a failed impurity specification detected during stability testing. No illnesses, injuries, or hospitalizations are reported in the source text, making this a precautionary recall with a theoretical rather than demonstrated hazard.

Plain-English summary

Perrigo Company PLC is recalling Amazon Basic+Care Allergy Fexofenadine Hydrochloride Tablets, 60 mg, 12-hour antihistamine in 100-count bottles (NDC 72288-425-78). The recall affects Lot # 1AR0558 with expiration date 7/31/2022. A total of 38,352 bottles were distributed nationwide in the USA by Amazon.com Services LLC.

The product is being recalled because impurity A was found to be out of specification during stability testing, meaning the level of this impurity exceeded acceptable limits.

Consumers who have purchased this product should stop using it and contact Amazon for instructions on how to return or dispose of the medication. The product was manufactured in the Czech Republic and should be identified by the lot number and expiration date on the packaging.

The recalled product

Product: amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Amazon.com services LLC 410 Terry Avenue N., Seattle WA 98109, NDC 72288-425-78 UPC 3 70030 14536 2
Manufacturer: Perrigo Company PLC
Category: Drug — Antihistamine / Oral Tablet
Hazard: impurity-out-of-specification
degradation
Affected units: 38,352

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 # 1AR0558
Exp 7/31/2022

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 out of specification