Sun Pharmaceutical Recalls Wal-Fex D Tablets Due to Impurity Testing Failures
Sun Pharmaceutical is recalling Wal-Fex D tablets because testing showed impurity levels above or near specification limits.
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: The recall is classified as FDA Class II, and the hazard involves impurities near or above specification limits without reported injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Wal-Fex D Fexofenadine HCl 60 mg/Pseudoephedrine HCl 120 mg Extended-Release Tablets. The recall involves 14,399 30-count units distributed nationwide in the USA by Walgreen Co. The affected lots are GKS1014 (EXP 09/2019) and GKT0484A (EXP 04/2020).
The recall was initiated because testing of Fexofenadine HCl and Pseudoephedrine failed impurities/degradation specifications. Specifically, elevated substance results were reported above or near the specification limit.
Consumers with these products should stop using them and contact their pharmacist or Sun Pharmaceutical for further instructions.
The recalled product
- Product
- Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets, USP, Allergy & Congestion, 30-count box. Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India. UPC 3 11917 19454 7
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Hazard
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 (4)
- Lot: GKS1014
- EXP 09/2019
- GKT0484A
- EXP 04/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Sun Pharmaceutical Industries, Inc. 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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