Wal-Fex Fexofenadine Tablets Recalled for Impurity Specifications
Perrigo Company is recalling Wal-Fex Fexofenadine Hydrochloride 60mg tablets due to out-of-specification impurity levels detected during stability testing. The recall affects 4,536 containers 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 manufacturing/specifications issue (impurity levels out of specification). No reported illnesses, injuries, or deaths are mentioned in the source text. The hazard is quality-related rather than an acute safety threat, warranting a Moderate severity rating.
Plain-English summary
Perrigo Company PLC is recalling Wal-Fex Fexofenadine Hydrochloride tablets, 60mg, 12-hour formulation in 24-count bottles, distributed by Walgreen Co. The recall was initiated due to failed impurities and degradation specifications, with an out-of-specification result obtained for impurity A during stability testing.
The affected product was manufactured in the Czech Republic and distributed nationwide in the USA. The recall includes 4,536 containers with the following lot numbers and expiration dates: Lot # 0KE2447 and 0KE2982 with expiration 01/31/2022, and Lot # 0ME2515 with expiration 04/30/2022 (NDC 0363-0903-62, UPC 3 11917 18625 2).
Consumers who have purchased this product should discontinue use and consult their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2
- Manufacturer
- Perrigo Company PLC
- Affected units
- 4,536
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 # 0KE2447
- 0KE2982
- Exp 01/31/2022
- 0ME2515
- Exp 04/30/2022
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.
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