# FDA recall D-0519-2020

> **X-Gen Pharmaceuticals Inc.** · Class III · drug recall initiated 2019-10-11.

## Product

Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1

## Reason for recall

Labeling: Incorrect or Missing Package Insert - the  incorrect package insert version was attached.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0519-2020
- **Recalling firm:** X-Gen Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-11
- **Report date:** 2019-11-27
- **Termination date:** 2022-08-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0519-2020

## Citation

> AI Analytics. FDA recall D-0519-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0519-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*