# FDA recall D-66014-001

> **Amneal Pharmaceuticals of New York, LLC.** · Class II · drug recall initiated 2013-08-17.

## Product

Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141

## Reason for recall

Failed dissolution specifications; 18 month CRT

## Distribution

IL, NH, NJ, NY, OH, RI, TN

## Key facts

- **Recall number:** D-66014-001
- **Recalling firm:** Amneal Pharmaceuticals of New York, LLC.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-17
- **Report date:** 2013-11-13
- **Termination date:** 2014-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hauppauge, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66014-001

## Citation

> AI Analytics. FDA recall D-66014-001. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-66014-001. Source: US FDA. Licensed CC0.

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