Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Class I - Dangerous

💊 Drugs Recalled: April 22, 2015 Wockhardt Usa Prescription Drugs Nationwide

What Should You Do?

Check if you have this product:
A) Lot #: DM12975, Expiry: 10/31/2015; Lot #: DM12976, Expiry: 10/31/2015; Lot #: DM12977, Expiry:10/31/2015; Lot #: DM12986, Expiry: 10/31/2015; Lot #: DM13259. Expiry: 10/31/2015; Lot #: DM13269, Expiry: 10/31/2015; Lot #: DM13270, Expiry: 11/30/2015; Lot #: DM13275, Expiry: 11/30/2015; Lot #: DM13339, Expiry: 11/30/2015; Lot #: DM13341, Expiry: 11/30/2015; Lot #: DM13369, Expiry: 11/30/2015; Lot #: DM13370, Expiry: 11/30/2015; Lot #: DN10088, Expiry: 12/31/2015; Lot #: DN10099, Expiry: 12/31/2015; Lot #: DN10939, Expiry: 3/31/2016; Lot #: DN10940, Expiry: 3/31/2016. B) Lot #: DM11422, Expiry: 5/31/2015; Lot #: DM11423, Expiry: 5/31/2015; Lot #: DM11424, Expiry: 5/31/2015; Lot #: DM11425, Expiry: 5/31/2015; Lot #: DM12634, Expiry: 9/30/2015; Lot #: DM12635; Expiry: 9/30/2015; Lot #: DM12660, Expiry: 9/30/2015; Lot #: DM12661, Expiry: 9/30/2015; Lot #: DM12662, Expiry: 9/30/2015; Lot #: DM12663, Expiry: 9/30/2015; Lot #: DM12673, Expiry: 9/30/2015; Lot #: DM12674, Expiry: 9/30/2015; Lot #: DM12684, Expiry: 9/30/2015; Lot #: DM12685, Expiry: 9/30/2015; Lot #: DM12985, Expiry: 10/31/2015; Lot #: DM13162, Expiry: 10/31/2015; Lot #: DM13163, Expiry: 10/31/2015; Lot #: DM13195, Expiry: 10/31/2015; Lot #: DM13196, Expiry: 10/31/2015; Lot #: DM13222, Expiry: 10/31/2015; Lot #: DM13223, Expiry: 10/31/2015; Lot #: DM13271, Expiry: 11/30/2015; Lot #: DM13272, Expiry: 11/30/2015; Lot #: DM13273, Expiry: 11/30/2015; Lot #: DM13274, Expiry: 11/30/2015; Lot #: DM13281, Expiry: 11/30/2015; Lot #: DM13282, Expiry: 11/30/2015; Lot #: DM13296, Expiry: 11/30/2015; Lot #: DM13297, Expiry: 11/30/2015: Lot #: DM13393, Expiry: 11/30/2015; Lot #: DM13394, Expiry: 11/30/2015; Lot #: DM13395, Expiry: 11/30/2015; Lot #: DM13403, Expiry: 11/30/2015; Lot #: DM13404, Expiry: 11/30/2015; Lot #: DM13415, Expiry: 11/30/2015; Lot #: DM13429, Expiry: 11/30/2015; Lot #: DN10077, Expiry: 12/31/2015; Lot #: DN10078, Expiry: 12/31/2015; Lot #: DN10079, Expiry: 12/31/2015; Lot #: DN10080, Expiry: 12/31/2015; Lot #: DN10081, Expiry: 12/31/2015; Lot #: DN10100, Expiry: 12/31/2015; Lot #: DN10104, Expiry: 12/31/2015; Lot #: DN10105, Expiry: 12/31/2015, Lot #: DN10336, Expiry: 12/31/2015; Lot #: DN10342, Expiry: 12/31/2015; Lot #: DN10343, Expiry: 12/31/2015; Lot #: DN10344, Expiry: 12/31/2015; Lot #: DN10355, Expiry: 12/31/2015; Lot #: DN10356, Expiry: 12/31/2015; Lot #: DN10811, Expiry: 2/29/2016; Lot #: DN10812, Expiry: 2/29/2016; Lot # DN10830, Expiry: 2/29/2016; Lot #: DN10874, Expiry: 2/29/2016; Lot #: DN10875, Expiry: 2/29/2016; Lot #: DN10876, Expiry: 2/29/2016; Lot #: DN10890, Expiry: 2/29/2016; Lot #: DN10891, Expiry: 2/29/2016; Lot #: DN10938, Expiry: 3/31/2016; Lot #: DN10956, Expiry: 3/31/2016.
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:

Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Product Codes/Lot Numbers:

A) Lot #: DM12975, Expiry: 10/31/2015; Lot #: DM12976, Expiry: 10/31/2015; Lot #: DM12977, Expiry:10/31/2015; Lot #: DM12986, Expiry: 10/31/2015; Lot #: DM13259. Expiry: 10/31/2015; Lot #: DM13269, Expiry: 10/31/2015; Lot #: DM13270, Expiry: 11/30/2015; Lot #: DM13275, Expiry: 11/30/2015; Lot #: DM13339, Expiry: 11/30/2015; Lot #: DM13341, Expiry: 11/30/2015; Lot #: DM13369, Expiry: 11/30/2015; Lot #: DM13370, Expiry: 11/30/2015; Lot #: DN10088, Expiry: 12/31/2015; Lot #: DN10099, Expiry: 12/31/2015; Lot #: DN10939, Expiry: 3/31/2016; Lot #: DN10940, Expiry: 3/31/2016. B) Lot #: DM11422, Expiry: 5/31/2015; Lot #: DM11423, Expiry: 5/31/2015; Lot #: DM11424, Expiry: 5/31/2015; Lot #: DM11425, Expiry: 5/31/2015; Lot #: DM12634, Expiry: 9/30/2015; Lot #: DM12635; Expiry: 9/30/2015; Lot #: DM12660, Expiry: 9/30/2015; Lot #: DM12661, Expiry: 9/30/2015; Lot #: DM12662, Expiry: 9/30/2015; Lot #: DM12663, Expiry: 9/30/2015; Lot #: DM12673, Expiry: 9/30/2015; Lot #: DM12674, Expiry: 9/30/2015; Lot #: DM12684, Expiry: 9/30/2015; Lot #: DM12685, Expiry: 9/30/2015; Lot #: DM12985, Expiry: 10/31/2015; Lot #: DM13162, Expiry: 10/31/2015; Lot #: DM13163, Expiry: 10/31/2015; Lot #: DM13195, Expiry: 10/31/2015; Lot #: DM13196, Expiry: 10/31/2015; Lot #: DM13222, Expiry: 10/31/2015; Lot #: DM13223, Expiry: 10/31/2015; Lot #: DM13271, Expiry: 11/30/2015; Lot #: DM13272, Expiry: 11/30/2015; Lot #: DM13273, Expiry: 11/30/2015; Lot #: DM13274, Expiry: 11/30/2015; Lot #: DM13281, Expiry: 11/30/2015; Lot #: DM13282, Expiry: 11/30/2015; Lot #: DM13296, Expiry: 11/30/2015; Lot #: DM13297, Expiry: 11/30/2015: Lot #: DM13393, Expiry: 11/30/2015; Lot #: DM13394, Expiry: 11/30/2015; Lot #: DM13395, Expiry: 11/30/2015; Lot #: DM13403, Expiry: 11/30/2015; Lot #: DM13404, Expiry: 11/30/2015; Lot #: DM13415, Expiry: 11/30/2015; Lot #: DM13429, Expiry: 11/30/2015; Lot #: DN10077, Expiry: 12/31/2015; Lot #: DN10078, Expiry: 12/31/2015; Lot #: DN10079, Expiry: 12/31/2015; Lot #: DN10080, Expiry: 12/31/2015; Lot #: DN10081, Expiry: 12/31/2015; Lot #: DN10100, Expiry: 12/31/2015; Lot #: DN10104, Expiry: 12/31/2015; Lot #: DN10105, Expiry: 12/31/2015, Lot #: DN10336, Expiry: 12/31/2015; Lot #: DN10342, Expiry: 12/31/2015; Lot #: DN10343, Expiry: 12/31/2015; Lot #: DN10344, Expiry: 12/31/2015; Lot #: DN10355, Expiry: 12/31/2015; Lot #: DN10356, Expiry: 12/31/2015; Lot #: DN10811, Expiry: 2/29/2016; Lot #: DN10812, Expiry: 2/29/2016; Lot # DN10830, Expiry: 2/29/2016; Lot #: DN10874, Expiry: 2/29/2016; Lot #: DN10875, Expiry: 2/29/2016; Lot #: DN10876, Expiry: 2/29/2016; Lot #: DN10890, Expiry: 2/29/2016; Lot #: DN10891, Expiry: 2/29/2016; Lot #: DN10938, Expiry: 3/31/2016; Lot #: DN10956, Expiry: 3/31/2016.