Home / Recalls / Wockhardt Usa Inc. / D-1275-2015

D-1275-2015 Class II Terminated

Recalled by Wockhardt Usa Inc. — Parsippany, NJ

FDA drug recall D-1275-2015 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) 162,743 Bottles and B) 14,205 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) 162,743 Bottles and B) 14,205 Bottles

Product description

Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), 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 #: LM10843, Expiry: 5/31/2015; Lot #: LM11331, Expiry: 7/31/2015; Lot #: LM11332, Expiry: 7/31/2015; Lot #: LM11376, Expiry: 7/31/2015; Lot #: LM11583, Expiry: 8/31/2015; Lot #: LM11987, Expiry: 11/30/2015; Lot #: LN10065, Expiry: 12/31/2015; Lot #: LN10066, Expiry: 12/31/2015; Lot #: LN10334, Expiry: 1/31/2016; Lot #: LN10335, Expiry: 1/31/2016; Lot #: LN10443, Expiry: 1/31/2016; Lot #: LN10879, Expiry: 4/30/2016; Lot #: LN10971, Expiry: 4/30/2016; Lot #: LN11178, Expiry: 6/30/2016; Lot #: LN11184, Expiry: 6/30/2016; Lot #: LN11348, Expiry: 7/31/2016. B) Lot #: LM10683, Expiry: 4/30/2015; Lot #: LM10842, Expiry: 5/31/2015; Lot #: LM11377, Expiry: 7/31/2015; Lot #: LM11584, Expiry: 8/31/2015; Lot #: LM11985, Expiry: 11/30/2015; Lot #: LM11988, Expiry: 11/30/2015; Lot #: LN10064, Expiry: 12/31/2015; Lot #: LN10336, Expiry: 1/31/2016; Lot #: LN10446, Expiry: 1/31/2016; Lot #: LN10880, Expiry: 4/30/2016; Lot #: LN10883, Expiry: 4/30/2016; Lot #: LN10972, Expiry: 4/30/2016; Lot #: LN11177, Expiry: 6/30/2016; Lot #: LN11256, Expiry: 7/31/2016.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1275-2015
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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