# FDA recall D-1539-2014

> **Mylan Pharmaceuticals Inc.** · Class III · drug recall initiated 2014-06-20.

## Product

Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only.  Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.

## Reason for recall

Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-1539-2014
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-06-20
- **Report date:** 2014-08-27
- **Termination date:** 2015-10-09

- **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-1539-2014

## Citation

> AI Analytics. FDA recall D-1539-2014. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1539-2014. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*