Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported November 27, 2019
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
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
X-Gen Pharmaceuticals Inc. recalled Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: … - a low-severity action.
Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: … was recalled by X-Gen Pharmaceuticals Inc. in November 27, 2019. Reason: Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.. Check the official notice for the remedy. Verify recall #D-0519-2020 with the FDA Drug before acting.
The recall
X-Gen Pharmaceuticals Inc. issued this low-severity FDA Drug recall-Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached..
- Low
- severity level
- Class III
- classification
- November 27, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0519-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0519-2020) was formally reported on November 27, 2019, with the manufacturer initiating the action on October 11, 2019. It is classified under Low severity (Class III), with a current status of Terminated. X-Gen Pharmaceuticals Inc. is listed as the recalling firm, operating out of Horseheads, NY. Federal records list the affected scope as 25120 vials.
The documented reason for this recall is: Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached. Distribution data in the federal record shows the product reached: U.S.A. Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
25120 vials
Related Recalls
6
5 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0519-2020 |
| Date reported | November 27, 2019 |
| Date initiated | October 11, 2019 |
| Recalling firm | X-Gen Pharmaceuticals Inc. |
| Firm location | Horseheads, NY |
| Affected scope | 25120 vials |
| Distribution | U.S.A. Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0519-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by X-Gen Pharmaceuticals Inc.. Units affected: 25120 vials.
Why was this product recalled? ▼
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 27, 2019. Severity: Low. Recall number: D-0519-2020.
Where was the recalled product distributed? ▼
Distribution: U.S.A. Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0519-2020) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported November 27, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.