Triamterene and Hydrochlorothiazide Tablets — Class III drug recall D-0631-2018
Terminated recall by Sandoz Incorporated, reported 2018-04-25, distributed nationwide. Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannito
| Recall number | D-0631-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Incorporated, Broomfield, CO, United States |
| Recall initiated | 2018-04-06 |
| Classified | 2018-04-16 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2019-04-08 |
| Distributed | Nationwide (US) |
| Quantity | 11,680 bottles |
| NDC | 00781-5067-05 |
| Lot numbers | 12/18, GW8264, HD3095 |
Product
Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.
Reason for recall
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
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-0631-2018. 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.