# FDA recall D-66458-1

> **Sandoz, Inc** · Class II · drug recall initiated 2013-10-09.

## Product

Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92

## Reason for recall

Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-66458-1
- **Recalling firm:** Sandoz, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-10-09
- **Report date:** 2013-11-13
- **Termination date:** 2014-07-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66458-1

## Citation

> AI Analytics. FDA recall D-66458-1. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-66458-1. Source: US FDA. Licensed CC0.

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