# FDA recall D-1468-2016

> **Mylan Institutional, Inc. (d.b.a. UDL Laboratories)** · Class II · drug recall initiated 2013-09-17.

## Product

Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV  26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL  61103.

## Reason for recall

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

## Distribution

Nationwide, Puerto Rico and Guam

## Key facts

- **Recall number:** D-1468-2016
- **Recalling firm:** Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-17
- **Report date:** 2016-08-31
- **Termination date:** 2018-04-24

- **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-1468-2016

## Citation

> AI Analytics. FDA recall D-1468-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1468-2016. Source: US FDA. Licensed CC0.

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