Levetiracetam Injection — Class III drug recall D-0519-2020
Terminated recall by X-Gen Pharmaceuticals Inc., reported 2019-11-27, distributed nationwide. Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
| Recall number | D-0519-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | X-Gen Pharmaceuticals Inc., Horseheads, NY, United States |
| Recall initiated | 2019-10-11 |
| Classified | 2019-11-21 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2022-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 25,120 vials |
| Reason classes | labeling |
| NDC | 39822-4000-01 |
| Lot numbers | 7051107, 7603333, 7603334, 7603335 |
| Expiration dates | 2020-05, 2022-01 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0519-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.