Home / Recalls / Wockhardt Usa Inc. / D-1244-2015

D-1244-2015 Class II Terminated

Recalled by Wockhardt Usa Inc. — Parsippany, NJ

FDA drug recall D-1244-2015 was initiated by Wockhardt Usa Inc. on Apr 22, 2015 and is designated Class II. Reason for recall: CGMP Deviations: Firm did not adequately investigate customer complaints. The recall status is terminated (terminated May 9, 2018). Affected quantity: A) 149,924 Bottles and B) 35,012 Bottles.

Recall details

Product Type: Drugs
Report Date: Jul 29, 2015
Initiation Date: Apr 22, 2015
Termination Date: May 9, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: A) 149,924 Bottles and B) 35,012 Bottles

Product description

Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Distribution pattern

U.S. Nationwide including Puerto Rico.

Code information

A) Lot #: DM10573, Expiry: 4/30/2015; Lot #: DM11531, Expiry: 5/31/2015; Lot #: DM11532, Expiry: 5/31/2015; Lot #: DM11676, Expiry: 6/30/2015; Lot #: DM11677, Expiry: 6/30/2015; Lot #: DM12543, Expiry: 8/31/2015; Lot #: DM13333, Expiry: 11/30/2015; Lot #: DN10272, Expiry: 12/31/2015; Lot #: DN10405, Expiry: 12/31/2015; Lot #: DN10446, Expiry: 1/1/2016. B) Lot #: DM11122, Expiry: 4/30/2015; Lot #: DM11130, Expiry: 4/30/2015; Lot #: DM11533, Expiry: 5/31/2015; Lot #: DM11674, Expiry: 6/30/2015; Lot #: DM11675, Expiry: 6/30/2015; Lot #: DM12497, Expiry: 8/31/2015; Lot #: DM13336, Expiry: 11/30/2015; Lot #: DN10289, Expiry: 12/31/2015; Lot #: DN10445, Expiry: 1/31/2016; Lot #: DN10816, Expiry: 1/31/2016; Lot #: DN10817, Expiry: 1/31/2016; Lot #: DN10976, Expiry: 2/29/2016.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1244-2015
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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