Sun Pharmaceutical Recalls Wal-Fex D Tablets Due to Impurity Testing Failures
Sun Pharmaceutical is recalling Wal-Fex D allergy and congestion 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 source text describes a quality control failure (impurities) without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 17,904 units of Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count boxes. The product is distributed by Walgreen Co. and was manufactured in India. The specific lot number is GKT0406 with an expiration date of 3/2020.
The recall was initiated because testing of the Fexofenadine HCl and Pseudoephedrine HCl components failed impurities and degradation specifications. The testing revealed elevated substance results that were reported above or near the specification limit.
The affected product was distributed nationwide in the USA. Consumers should check their medication for the specific lot number GKT0406 and expiration date 3/2020. If they have this product, they should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distributed by: Walgreen Co. 200 Wilmore Rd. Deerfield, IL 40015. Made in India UPC 3 11917 19453 0
- 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 (2)
- Lot GKT0406
- EXP 3/2020
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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