CLASS II Drug recall · Reported 2 Dec 2020 · FDA Enforcement Report
Levetiracetam Tablets, USP 500 mg recalled by Eywa Pharma
Eywa Pharma is recalling Levetiracetam Tablets, USP 500 mg, distributed nationwide in the US. The recall was initiated on 10 Nov 2020 and the FDA has classified it as Class II.
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-0109-2021
- FDA event ID
- 86740
- Recalling firm
- Eywa Pharma, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Nov 2020
- FDA classified
- 25 Nov 2020
- Reported
- 2 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Seizure Medication
Timeline
| 10 Nov 2020 | Recall initiated by company | |
| 25 Nov 2020 | Classified by FDA | +15 days |
| 2 Dec 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
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 Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Which lots are affected?
Lot #: LEV5019021A, Exp 10/2021
Where was it sold?
USA 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 750 mg recalled by Aurobindo Pharma USALevetiracetam | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |