CLASS II Drug recall · Reported 18 Feb 2015 · FDA Enforcement Report
Levetiracetam, extended release tablets, 750 mg recalled
Sun Pharma Global Fze is recalling Levetiracetam, extended release tablets, 750 mg, distributed nationwide in the US. The recall was initiated on 21 Jan 2015 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-0386-2015
- FDA event ID
- 70339
- Recalling firm
- Sun Pharma Global Fze, Sharm, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2015
- FDA classified
- 12 Feb 2015
- Reported
- 18 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 21 Jan 2015 | Recall initiated by company | |
| 12 Feb 2015 | Classified by FDA | +22 days |
| 18 Feb 2015 | 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
Failed Dissolution Specifications: 6 month time point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC Number: 47335-576-86
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: 6 month time point.
Which lots are affected?
Lot #: JKN0249A Exp 02/2016
Where was it sold?
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.
More recalls from Sun Pharma Global Fze
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alendronate Sodium Tablets, USP, 70 mg* blisters recalled | Sun Pharma Global Fze | Potency & Assay | Nationwide |
| Drug | CLASS III | buPROPion Hydrochloride Extended-¿release Tablets USP (SR) recalledBupropion Hydrochloride | Sun Pharma Global Fze | Potency & Assay | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled | Sun Pharma Global Fze | 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 |