Fosinopril Sodium and Hydrochlorothiazide Tablets — Class II drug recall D-393-2014
Terminated recall by Sandoz Inc, reported 2014-01-08, distributed nationwide. Subpotent; Hydrochlorothiazide at the 9 month time point.
| Recall number | D-393-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Wilson, NC, United States |
| Recall initiated | 2013-10-11 |
| Classified | 2013-12-30 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2015-03-05 |
| Distributed | Nationwide (US) |
| Reason classes | potency |
| NDC | 00185-0341-01 |
| Lot numbers | CU0856 |
Product
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
Reason for recall
Subpotent; Hydrochlorothiazide at the 9 month time point.
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-393-2014. 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.