Triamterene and Hydrochlorothiazide Tablets — Class III drug recall D-0978-2018
Terminated recall by Mylan Pharmaceuticals Inc., reported 2018-07-18, distributed nationwide. Subpotent Drug
| Recall number | D-0978-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2018-07-09 |
| Classified | 2018-07-24 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2020-01-16 |
| Distributed | Nationwide (US) |
| Quantity | 28,436 bottles |
| Reason classes | potency |
| NDC | 00378-1352-01 |
| Lot numbers | 2007979 |
| Expiration dates | 2020-11-30 |
Product
Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
Reason for recall
Subpotent Drug
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-0978-2018. 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.