H.E.B Allergy Relief Fexofenadine tablets recalled for impurity specification failure
Perrigo Company is recalling H.E.B Allergy Relief fexofenadine hydrochloride 60mg tablets nationwide due to failure of impurity specifications during stability testing.
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 for a drug with no reported illnesses or injuries. The hazard involves impurity specification failure during stability testing, which is a manufacturing/quality issue rather than an acute safety event with documented harm. This fits the Moderate category for low-risk manufacturing defects.
Plain-English summary
Perrigo Company PLC is recalling H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg antihistamine in 12-count bottles nationwide in the USA. The recall affects NDC 37808-425-53 (UPC 0 41220 53080 9), manufactured in the Czech Republic for H.E.B in San Antonio, Texas.
The recall was initiated due to failed impurities and degradation specifications. During stability testing, an out-of-specification result was obtained for impurity A in affected lots.
The affected lots are: 0JE2491 with expiration date 01/31/2022, 0LE2178 with expiration date 01/31/2022, and 0ME2516 with expiration date 04/30/2022. A total of 26,304 containers were distributed.
Consumers who have purchased this product should stop use and consult their healthcare provider or pharmacist for guidance on alternative allergy relief options.
The recalled product
- Product
- H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9
- Manufacturer
- Perrigo Company PLC
- Hazard
- impurity-degradation
- specification-failure
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 (5)
- Lot 0JE2491
- 0LE2178
- Exp 01/31/2022
- 0ME2516
- Exp 4/30/2022
Distribution
Distributed nationwide across the United States.
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