CLASS II Drug recall · Reported 29 Jul 2015 · FDA Enforcement Report
Zonisamide Capsules recalled by Wockhardt Usa
Wockhardt Usa is recalling Zonisamide Capsules, distributed nationwide in the US. The recall was initiated on 22 Apr 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-1273-2015
- FDA event ID
- 71104
- Recalling firm
- Wockhardt Usa, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Apr 2015
- FDA classified
- 17 Jul 2015
- Reported
- 29 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 22 Apr 2015 | Recall initiated by company | |
| 17 Jul 2015 | Classified by FDA | +86 days |
| 29 Jul 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Product as listed by the FDA
Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0946-01.
Where it was distributed
U.S. Nationwide including Puerto Rico.
Stores named: Walmart
Questions about this recall
Is Zonisamide Capsules recalled?
Yes. Wockhardt Usa recalled Zonisamide Capsules on 22 Apr 2015. The recall is Class II and its status is Terminated. Recall number D-1273-2015.
Why was it recalled?
CGMP Deviations: Firm did not adequately investigate customer complaints.
Which lots are affected?
Lot #: LM10769, Expiry: 4/30/2015; Lot #: LM10770, Expiry: 4/30/2015; Lot #: LM10771, Expiry: 4/30/2015; Lot #: LM10875, Expiry: 5/31/2015; Lot #: LM10876, Expiry: 5/31/2015; Lot #: LM11145, Expiry: 6/30/2015; Lot #: LM11174, Expiry: 6/30/2015; Lot #: LM11175, Expiry: 6/30/2015; Lot #: LM11226, Expiry: 7/31/2015; Lot #: LM11227, Expiry: 7/31/2015; Lot #: LM11289, Expiry: 7/31/2015; Lot #: LM11290, Expiry: 7/31/2015; Lot #: LM11544, Expiry: 8/31/2015; Lot #: LM11545, Expiry: 8/31/2015; Lot #: LM11671, Expiry: 9/30/2015; Lot #: LM11947, Expiry: 10/31/2015; Lot #: LM11948, Expiry: 10/31/2015; Lot #: LM11949, Expiry: 10/31/2015; Lot #: LM11950, Expiry: 10/31/2015; Lot #: LN10208, Expiry: 12/31/2015; Lot #: LN10209, Expiry: 12/31/2015; Lot #: LN10210, Expiry: 12/31/2015; Lot #: LN10211, Expiry: 12/31/2015; Lot #: LN10212, Expiry: 12/31/2015; Lot #: LN10213, Expiry: 12/31/2015; Lot #: LN10354, Expiry: 1/31/2016; Lot #: LN10355, Expiry: 1/31/2016; Lot #: LN10526, Expiry: 2/29/2016; Lot #: LN10527, Expiry: 2/29/2016; Lot #: LN10528, Expiry: 2/29/2016; Lot #: LN10529, Expiry: 2/29/2016; Lot #: LN10541, Expiry: 2/29/2016; Lot #: LN10840, Expiry: 4/30/2016; Lot #: LN11113, Expiry: 5/31/2016; Lot #: LN11333, Expiry: 7/31/2016; Lot #: LN11377, Expiry: 8/31/2016.
Where was it sold?
U.S. Nationwide including Puerto Rico.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Zonisamide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zonisamide Capsules USP, 100 mg recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zonisamide Capsules, USP, 100 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zonisamide Capsules USP, 25 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zonisamide Capsules, USP, 50 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Zonisamide Capsules USP 100 mg recalled by Glenmark PharmaceuticalsZonisamide | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |