Zonisamide Capsules, 100 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: 64679-0990-01.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: LM10776, Expiry: 5/31/2015; Lot #: LM10781, Expiry: 5/31/2015; Lot #: LM10783, Expiry: 5/31/2015; Lot #: LM10923, Expiry: 4/30/2015; Lot #: LM10924, Expiry: 4/30/2015; Lot #: LM10925, Expiry: 4/30/2015; Lot #: LM10926, Expiry: 5/31/2015; Lot #: LM10927, Expiry: 5/31/2015; Lot #: LM10937, Expiry: 6/30/2015; Lot #: LM11138, Expiry: 6/30/2015; Lot #: LM11139, Expiry: 6/30/2015; Lot #: LM11141, Expiry: 6/30/2015; Lot #: LM11180, Expiry: 6/30/2015; Lot #: LM11181, Expiry: 6/30/2015; Lot #: LM11319, Expiry: 7/31/2015; Lot #: LM11320, Expiry: 7/31/2015; Lot #: LM11356, Expiry: 7/31/2015; Lot #: LM11357, Expiry: 7/31/2015; Lot #: LM11363, Expiry: 7/31/2015; Lot #: LM11407, Expiry: 7/31/2015; Lot #: LM11558, Expiry: 8/31/2015; Lot #: LM11730, Expiry: 9/30/2015; Lot #: LM11737, Expiry: 9/30/2015; Lot #: LM11744, Expiry: 9/30/2015, Lot #: LM11754, Expiry: 9/30/2015; Lot #: LM11860, Expiry: 10/31/2015; Lot #: LM11861, Expiry: 10/31/2015; Lot #: LM11904, Expiry: 10/31/2015; Lot #: LM11905, Expiry: 10/31/2015; Lot #: LM11906, Expiry: 10/31/2015; Lot #: LM11964, Expiry: 11/30/2015; Lot #: LN10127, Expiry: 12/31/2015; Lot #: LN10128, Expiry: 12/31/2015; Lot #: LN10137, Expiry: 12/31/2015; Lot #: LN10138, Expiry: 12/31/2015; Lot #: LN10139, Expiry: 12/31/2015; Lot #: LN10140, Expiry: 12/31/2015; Lot #: LN10223, Expiry: 12/31/2015; Lot #: LN10224, Expiry: 12/31/2015; Lot #: LN10235, Expiry: 1/31/2016; Lot #: LN10236, Expiry: 1/31/2016; Lot #: LN10361, Expiry: 1/31/2016; Lot #: LN10362, Expiry: 1/31/2016; Lot #: LN10550, Expiry: 2/29/2016; Lot #: LN10551, Expiry: 2/29/2016; Lot #: LN10552, Expiry: 2/29/2016; Lot #: LN10553, Expiry: 2/29/2016; Lot #: LN10554, Expiry: 2/29/2016; Lot #: LN10606, Expiry: 2/29/2016; Lot #: LN10613, Expiry: 2/29/2016; Lot #: LN10681, Expiry: 3/31/2016; Lot #: LN10752, Expiry: 3/31/2016; Lot #: LN10753, Expiry: 3/31/2016; Lot #: LN10847, Expiry: 4/30/2016; Lot #: LN10944, Expiry: 4/30/2016; Lot #: LN10954, Expiry: 4/30/2016; Lot #: LN10955, Expiry: 4/30/2016; Lot #: LN11091, Expiry: 5/31/2016; Lot #: LN11092, Expiry: 5/31/2016; Lot #: LN11104, Expiry: 5/31/2016; Lot #: LN11112, Expiry: 5/31/2016; Lot #: LN11231, Expiry: 6/30/2016; Lot #: LN11232, Expiry: 6/30/2016; Lot #: LN11241, Expiry: 7/31/2016; Lot #: LN11282, Expiry: 7/31/2016; Lot #: LN11355, Expiry: 8/31/2016; Lot #: LN11358, Expiry: 8/31/2016; Lot #: LN11361, Expiry: 8/31/2016; Lot #: LN11399, Expiry: 9/30/2016.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Wockhardt Usa Inc.
- Reason for Recall:
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Zonisamide Capsules, 100 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: 64679-0990-01.
Product Codes/Lot Numbers:
Lot #: LM10776, Expiry: 5/31/2015; Lot #: LM10781, Expiry: 5/31/2015; Lot #: LM10783, Expiry: 5/31/2015; Lot #: LM10923, Expiry: 4/30/2015; Lot #: LM10924, Expiry: 4/30/2015; Lot #: LM10925, Expiry: 4/30/2015; Lot #: LM10926, Expiry: 5/31/2015; Lot #: LM10927, Expiry: 5/31/2015; Lot #: LM10937, Expiry: 6/30/2015; Lot #: LM11138, Expiry: 6/30/2015; Lot #: LM11139, Expiry: 6/30/2015; Lot #: LM11141, Expiry: 6/30/2015; Lot #: LM11180, Expiry: 6/30/2015; Lot #: LM11181, Expiry: 6/30/2015; Lot #: LM11319, Expiry: 7/31/2015; Lot #: LM11320, Expiry: 7/31/2015; Lot #: LM11356, Expiry: 7/31/2015; Lot #: LM11357, Expiry: 7/31/2015; Lot #: LM11363, Expiry: 7/31/2015; Lot #: LM11407, Expiry: 7/31/2015; Lot #: LM11558, Expiry: 8/31/2015; Lot #: LM11730, Expiry: 9/30/2015; Lot #: LM11737, Expiry: 9/30/2015; Lot #: LM11744, Expiry: 9/30/2015, Lot #: LM11754, Expiry: 9/30/2015; Lot #: LM11860, Expiry: 10/31/2015; Lot #: LM11861, Expiry: 10/31/2015; Lot #: LM11904, Expiry: 10/31/2015; Lot #: LM11905, Expiry: 10/31/2015; Lot #: LM11906, Expiry: 10/31/2015; Lot #: LM11964, Expiry: 11/30/2015; Lot #: LN10127, Expiry: 12/31/2015; Lot #: LN10128, Expiry: 12/31/2015; Lot #: LN10137, Expiry: 12/31/2015; Lot #: LN10138, Expiry: 12/31/2015; Lot #: LN10139, Expiry: 12/31/2015; Lot #: LN10140, Expiry: 12/31/2015; Lot #: LN10223, Expiry: 12/31/2015; Lot #: LN10224, Expiry: 12/31/2015; Lot #: LN10235, Expiry: 1/31/2016; Lot #: LN10236, Expiry: 1/31/2016; Lot #: LN10361, Expiry: 1/31/2016; Lot #: LN10362, Expiry: 1/31/2016; Lot #: LN10550, Expiry: 2/29/2016; Lot #: LN10551, Expiry: 2/29/2016; Lot #: LN10552, Expiry: 2/29/2016; Lot #: LN10553, Expiry: 2/29/2016; Lot #: LN10554, Expiry: 2/29/2016; Lot #: LN10606, Expiry: 2/29/2016; Lot #: LN10613, Expiry: 2/29/2016; Lot #: LN10681, Expiry: 3/31/2016; Lot #: LN10752, Expiry: 3/31/2016; Lot #: LN10753, Expiry: 3/31/2016; Lot #: LN10847, Expiry: 4/30/2016; Lot #: LN10944, Expiry: 4/30/2016; Lot #: LN10954, Expiry: 4/30/2016; Lot #: LN10955, Expiry: 4/30/2016; Lot #: LN11091, Expiry: 5/31/2016; Lot #: LN11092, Expiry: 5/31/2016; Lot #: LN11104, Expiry: 5/31/2016; Lot #: LN11112, Expiry: 5/31/2016; Lot #: LN11231, Expiry: 6/30/2016; Lot #: LN11232, Expiry: 6/30/2016; Lot #: LN11241, Expiry: 7/31/2016; Lot #: LN11282, Expiry: 7/31/2016; Lot #: LN11355, Expiry: 8/31/2016; Lot #: LN11358, Expiry: 8/31/2016; Lot #: LN11361, Expiry: 8/31/2016; Lot #: LN11399, Expiry: 9/30/2016.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1254-2015
Related Recalls
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.