FDA Drug recall D-1243-2015

Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only

FDA Drug
Class II
terminated
Published 2015-07-29

On 2015-07-29 the FDA classified a Class II recall of Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only 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-1243-2015
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, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.

Reason

CGMP Deviations: Firm did not adequately investigate customer complaints.

Identifiers

code_info	Lot #: DM11774, Expiry: 6/30/2015; Lot #: DM13056, Expiry: 10/31/2015; Lot #: DM13117, Expiry: 10/31/2015; Lot #: DM131… Lot #: DM11774, Expiry: 6/30/2015; Lot #: DM13056, Expiry: 10/31/2015; Lot #: DM13117, Expiry: 10/31/2015; Lot #: DM13159, Expiry: 10/31/2015; Lot #: DM13186, Expiry: 10/31/2015; Lot #: DM13187, Expiry: 10/31/2015; Lot #: DM13188, Expiry: 10/31/2015; Lot #: DN10003, Expiry: 11/30/2015; Lot #: DN10045, Expiry: 11/30/2015; Lot #: DN10046, Expiry: 11/30/2015; Lot #: DN10389, Expiry: 1/31/2016; Lot #: DN10412, Expiry: 1/31/2016; Lot #: DN10604, Expiry: 1/31/2016.

code_info

Lot #: DM11774, Expiry: 6/30/2015; Lot #: DM13056, Expiry: 10/31/2015; Lot #: DM13117, Expiry: 10/31/2015; Lot #: DM131…

Lot #: DM11774, Expiry: 6/30/2015; Lot #: DM13056, Expiry: 10/31/2015; Lot #: DM13117, Expiry: 10/31/2015; Lot #: DM13159, Expiry: 10/31/2015; Lot #: DM13186, Expiry: 10/31/2015; Lot #: DM13187, Expiry: 10/31/2015; Lot #: DM13188, Expiry: 10/31/2015; Lot #: DN10003, Expiry: 11/30/2015; Lot #: DN10045, Expiry: 11/30/2015; Lot #: DN10046, Expiry: 11/30/2015; Lot #: DN10389, Expiry: 1/31/2016; Lot #: DN10412, Expiry: 1/31/2016; Lot #: DN10604, Expiry: 1/31/2016.

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-1243-2015%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.