FDA Drug recall D-1096-2018
Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256
- FDA Drug
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256 by Northwind Pharmaceuticals, citing CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1096-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-18 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Northwind Pharmaceuticals |
| Distribution | IN |
Product
Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-950-52
Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Identifiers
| code_info | Lot: UTB23790003, exp 02/28/2019 |
|---|
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-1096-2018%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.