Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/… — Class II drug recall D-1389-2019
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2019-06-26, distributed nationwide. Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substan
| Recall number | D-1389-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2019-06-05 |
| Classified | 2019-06-14 |
| Reported by FDA | 2019-06-26 |
| Terminated | 2021-01-08 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00311917194547 |
| Lot numbers | GKS1014, GKT0484A |
| Expiration dates | 2019-09, 2020-04 |
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
Reason for recall
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1389-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.