# FDA recall D-452-2013

> **Mylan Institutional, Inc. (d.b.a. UDL Laboratories)** · Class III · drug recall initiated 2013-05-15.

## Product

Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV  26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL  61103, NDC 51079-020-03.

## Reason for recall

Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-452-2013
- **Recalling firm:** Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-15
- **Report date:** 2013-05-29
- **Termination date:** 2015-05-07

- **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-452-2013

## Citation

> AI Analytics. FDA recall D-452-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-452-2013. Source: US FDA. Licensed CC0.

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