# FDA recall D-0336-2015

> **Actavis Elizabeth LLC** · Class II · drug recall initiated 2014-12-15.

## Product

Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.

## Reason for recall

Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

## Distribution

Puerto Rico

## Key facts

- **Recall number:** D-0336-2015
- **Recalling firm:** Actavis Elizabeth LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-12-15
- **Report date:** 2015-01-14
- **Termination date:** 2015-11-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0336-2015

## Citation

> AI Analytics. FDA recall D-0336-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0336-2015. Source: US FDA. Licensed CC0.

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