CLASS III Drug recall · Reported 27 Nov 2019 · FDA Enforcement Report
Levetiracetam Injection, 500 mg/-use vials recalled
X-Gen Pharmaceuticals is recalling Levetiracetam Injection, 500 mg/-use vials, distributed nationwide in the US. The recall was initiated on 11 Oct 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0519-2020
- FDA event ID
- 84027
- Recalling firm
- X-Gen Pharmaceuticals, Horseheads, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Oct 2019
- FDA classified
- 21 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Oct 2019 | Recall initiated by company | |
| 21 Nov 2019 | Classified by FDA | +41 days |
| 27 Nov 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Which lots are affected?
Lot #: 7603333, 7603334, 7603335, Exp 05/2020; 7051107, Exp 01/2022
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from X-Gen Pharmaceuticals
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cyclophosphamide for Injection, USP, 500mg/vial recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Cyclophosphamide for Injection, USP, Lyophilized recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Neomycin Sulfate Tablets, USP 500mg recalled by X-Gen Pharmaceuticals | X-Gen Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Clonidine HCL Injection, 1000 mcg/ (100 mcg/mL) Single Dose Vial recalledClonidine | X-Gen Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Nystatin Topical Powder, USP, 100,000 USP units per gram recalled | X-Gen Pharmaceuticals | Particulate Matter | Nationwide |
Other Levetiracetam recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS II | Levetiracetam Oral Solution 100 mg/mL (100 mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Levetiracetam Tablets USP, 250 mg UD recalled by McKesson | McKesson | Other | Nationwide |
| Drug | CLASS II | Levetiracetam Oral Solution, 100 mg/mL recalled by Akorn | Akorn | Packaging Defects | Nationwide |
| Drug | CLASS II | Levetiracetam Tablets, USP 500 mg recalled by Eywa Pharma | Eywa Pharma | Packaging Defects | Nationwide |