# FDA recall D-0877-2018

> **Mylan Pharmaceuticals Inc.** · Class III · drug recall initiated 2018-06-07.

## 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.

## Distribution

Product was distributed throughout the United States

## Key facts

- **Recall number:** D-0877-2018
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-06-07
- **Report date:** 2018-06-20
- **Termination date:** 2019-06-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morgantown, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0877-2018

## Citation

> AI Analytics. FDA recall D-0877-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0877-2018. Source: US FDA. Licensed CC0.

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