Maxzide-25 — Class III drug recall D-0877-2018
Terminated recall by Mylan Pharmaceuticals Inc., reported 2018-06-20, distributed nationwide. Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specif
| Recall number | D-0877-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2018-06-07 |
| Classified | 2018-06-15 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2019-06-20 |
| Distributed | Nationwide (US) |
| Quantity | 1,620 bottles |
| Reason classes | potency, specification failure |
| NDC | 00378-0464-01 |
| Lot numbers | 3087136, 5/20 |
Product
Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
Reason for recall
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
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-0877-2018. 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.