Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), 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 #: DM11421, Expiry: 5/31/2015; Lot #: DM12956, Expiry: 10/31/2015; Lot #: DM12957, Expiry: 10/31/2015; Lot #: DM12963, Expiry: 10/31/2015; Lot #: DM13242, Expiry: 11/30/2015; Lot #: DM13243, Expiry: 11/30/2015; Lot #: DM13251, Expiry: 11/30/2015; Lot #: DM13260, Expiry: 11/30/2015; Lot #: DN10138, Expiry: 12/31/2015. B) Lot #: DM11035, Expiry: 4/30/2015; Lot #: DM11088, Expiry: 4/30/2015; Lot #: DM11389, Expiry: 5/31/2015; Lot #: DM11393, Expiry: 5/31/2015; Lot #: DM11394, Expiry: 5/31/2015; Lot #: DM12632, Expiry: 9/30/2015; Lot #: DM12633, Expiry: 9/30/2015; Lot #: DM12650, Expiry: 9/30/2015; Lot #: DM12651, Expiry: 9/30/2015; Lot #: DM12667, Expiry: 5/31/2015; Lot #: DM12964, Expiry: 10/31/2015; Lot #: DM13086, Expiry: 10/31/2015; Lot #: DM13155, Expiry: 10/31/2015; Lot #: DM13156, Expiry: 10/31/2015; Lot #: DM13157, Expiry: 10/31/2015; Lot #: DM13158, Expiry: 10/31/2015; Lot #: DM13184, Expiry: 10/31/2015; Lot #: DM13206, Expiry: 10/31/2015; Lot #: DM13207, Expiry: 10/31/2015; Lot #: DM13266, Expiry: 11/30/2015; Lot #: DM13267, Expiry: 11/30/2015; Lot #: DM13268, Expiry: 11/30/2015; Lot #: DM13283, Expiry: 11/30/2015; Lot #: DM13325, Expiry: 11/30/2015; Lot #: DN10058, Expiry: 12/31/2015; Lot #: DN10059; Expiry: 12/31/2015; Lot #: DN10060, Expiry: 12/31/2015; Lot #: DN10061, Expiry: 12/31/2015; Lot #: DN10062, Expiry: 12/31/2015; Lot #: DN10307, Expiry: 12/31/2015; Lot #: DN10308, Expiry: 12/31/2015; Lot #: DN10324, Expiry: 12/31/2015; Lot #: DN10346, Expiry: 12/31/2015; Lot #: DN10809, Expiry: 2/29/2016; Lot #: DN10810, Expiry: 2/29/2016; Lot #: DN10840, Expiry: 2/29/2016; Lot #: DN10877, Expiry: 2/29/2016; Lot #: DN10878, Expiry: 2/29/2016; Lot #: DN10904, Expiry: 2/29/2016; Lot #: DN10905, Expiry: 2/29/2016; Lot #: DN10921, Expiry: 2/29/2016; Lot #: DN10942, Expiry: 3/31/2016; Lot #: DN10943, Expiry: 3/31/2016; Lot #: DN10972, 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, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), 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 #: DM11421, Expiry: 5/31/2015; Lot #: DM12956, Expiry: 10/31/2015; Lot #: DM12957, Expiry: 10/31/2015; Lot #: DM12963, Expiry: 10/31/2015; Lot #: DM13242, Expiry: 11/30/2015; Lot #: DM13243, Expiry: 11/30/2015; Lot #: DM13251, Expiry: 11/30/2015; Lot #: DM13260, Expiry: 11/30/2015; Lot #: DN10138, Expiry: 12/31/2015. B) Lot #: DM11035, Expiry: 4/30/2015; Lot #: DM11088, Expiry: 4/30/2015; Lot #: DM11389, Expiry: 5/31/2015; Lot #: DM11393, Expiry: 5/31/2015; Lot #: DM11394, Expiry: 5/31/2015; Lot #: DM12632, Expiry: 9/30/2015; Lot #: DM12633, Expiry: 9/30/2015; Lot #: DM12650, Expiry: 9/30/2015; Lot #: DM12651, Expiry: 9/30/2015; Lot #: DM12667, Expiry: 5/31/2015; Lot #: DM12964, Expiry: 10/31/2015; Lot #: DM13086, Expiry: 10/31/2015; Lot #: DM13155, Expiry: 10/31/2015; Lot #: DM13156, Expiry: 10/31/2015; Lot #: DM13157, Expiry: 10/31/2015; Lot #: DM13158, Expiry: 10/31/2015; Lot #: DM13184, Expiry: 10/31/2015; Lot #: DM13206, Expiry: 10/31/2015; Lot #: DM13207, Expiry: 10/31/2015; Lot #: DM13266, Expiry: 11/30/2015; Lot #: DM13267, Expiry: 11/30/2015; Lot #: DM13268, Expiry: 11/30/2015; Lot #: DM13283, Expiry: 11/30/2015; Lot #: DM13325, Expiry: 11/30/2015; Lot #: DN10058, Expiry: 12/31/2015; Lot #: DN10059; Expiry: 12/31/2015; Lot #: DN10060, Expiry: 12/31/2015; Lot #: DN10061, Expiry: 12/31/2015; Lot #: DN10062, Expiry: 12/31/2015; Lot #: DN10307, Expiry: 12/31/2015; Lot #: DN10308, Expiry: 12/31/2015; Lot #: DN10324, Expiry: 12/31/2015; Lot #: DN10346, Expiry: 12/31/2015; Lot #: DN10809, Expiry: 2/29/2016; Lot #: DN10810, Expiry: 2/29/2016; Lot #: DN10840, Expiry: 2/29/2016; Lot #: DN10877, Expiry: 2/29/2016; Lot #: DN10878, Expiry: 2/29/2016; Lot #: DN10904, Expiry: 2/29/2016; Lot #: DN10905, Expiry: 2/29/2016; Lot #: DN10921, Expiry: 2/29/2016; Lot #: DN10942, Expiry: 3/31/2016; Lot #: DN10943, Expiry: 3/31/2016; Lot #: DN10972, Expiry: 3/31/2016.