MAJOR Fexofenadine Hydrochloride 60mg tablets recalled for failed impurity specifications
Perrigo Company PLC is recalling MAJOR brand Fexofenadine Hydrochloride 12HR 60mg antihistamine tablets due to failed impurities and degradation specifications detected 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: The source material indicates an FDA Class II recall with no reported illnesses or injuries. The hazard is based on failed quality specifications during stability testing, representing a quality control issue rather than confirmed harm or high-risk pathogen contamination.
Plain-English summary
Perrigo Company PLC is recalling MAJOR Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottles, distributed nationwide in the USA. The recall affects approximately 65,796 containers.
The recall is due to failed impurities and degradation specifications. During stability testing, an out-of-specification result was obtained for impurity A.
The affected product was manufactured in the Czech Republic and distributed by Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. The recalled lots are: Lot 0GR0445 (Exp 1/31/2022), Lot 0LR0361 (Exp 4/30/2022), and Lot 1AR0558 (Exp 7/31/2022). The product is identified by NDC 0904-6979-60 and UPC 3 09046 97960 9.
Consumers who have purchased this product should consult with their pharmacist or healthcare provider regarding continued use.
The recalled product
- Product
- MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Antihistamine
- Hazard
- failed-impurity-specification
- degradation
- quality-control
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 (6)
- Lot 0GR0445
- Exp 1/31/2022
- 0LR0361
- Exp 4/30/2022
- 1AR0558
- Exp 7/31/2022
Distribution
Distributed nationwide across the United States.
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