# FDA recall D-1435-2014

> **Mylan Institutional, Inc. (d.b.a. UDL Laboratories)** · Class III · drug recall initiated 2014-07-03.

## Product

Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV  26505, NDC 51079-947-08.

## Reason for recall

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

## Distribution

Nationwide, Puerto Rico, and Guam.

## Key facts

- **Recall number:** D-1435-2014
- **Recalling firm:** Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-07-03
- **Report date:** 2014-07-23
- **Termination date:** 2016-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockford, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1435-2014

## Citation

> AI Analytics. FDA recall D-1435-2014. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1435-2014. Source: US FDA. Licensed CC0.

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