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.
What this means for you
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
- Hazard
- impurity-out-of-specification
- degradation
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.
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