FDA Drug recall D-1255-2015

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…

FDA Drug
Class II
terminated
Published 2015-07-29

On 2015-07-29 the FDA classified a Class II recall of 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… by Wockhardt Usa, citing CGMP Deviations: Firm did not adequately investigate customer complaints.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1255-2015
Classification	Class II
Status	terminated
Initiated	2015-04-22
Published	2015-07-29
Last updated	2026-09-13 11:51 UTC
Company	Wockhardt Usa
Distribution	US

Product

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.

Reason

CGMP Deviations: Firm did not adequately investigate customer complaints.

Identifiers

code_info	A) Lot #: DM11421, Expiry: 5/31/2015; Lot #: DM12956, Expiry: 10/31/2015; Lot #: DM12957, Expiry: 10/31/2015; Lot #: DM… 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/

code_info

A) Lot #: DM11421, Expiry: 5/31/2015; Lot #: DM12956, Expiry: 10/31/2015; Lot #: DM12957, Expiry: 10/31/2015; Lot #: DM…

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/

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1255-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.