FDA Drug recall D-1390-2019
Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distributed…
- FDA Drug
- Class II
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets, USP, Allergy & Congestion, 20-count box.Distributed… by Sun Pharmaceutical Industries, citing testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1390-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-05 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Reason
Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit
Identifiers
| upc | 311917194530 |
|---|---|
| code_info | Lot GKT0406, EXP 3/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1390-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.