D-1261-2015 Class II Terminated
FDA drug recall D-1261-2015 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) 174,571 Bottles, B) 66,960 Bottles, and C) 48,988 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) 174,571 Bottles, B) 66,960 Bottles, and C) 48,988 Bottles.
Product description
Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), 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 #: DM11040, Expiry: 4/30/2015; Lot #: DM11463, Expiry: 5/31/2015; Lot #: DM11497, Expiry: 5/31/2015; Lot #: DM11498, Expiry: 5/31/2015; Lot #: DM12126, Expiry: 7/31/2015; Lot #: DM12132, Expiry: 7/31/2015; Lot #: DM12172, Expiry: 7/31/2015; Lot #: DM12176, Expiry: 7/31/2015; Lot #: DN10325, Expiry: 12/31/2015; Lot #: DN10892, Expiry: 2/29/2016. B) Lot #: DM11812, Expiry: 6/30/2015; Lot #: DM11816, Expiry: 6/30/2015; Lot #: DM11821, Expiry: 6/30/2015; Lot #: DM11822, Expiry: 6/30/2015; Lot #: DM11827, Expiry: 6/30/2015; Lot #: DM11828, Expiry: 6/30/2015; Lot #: DM11853, Expiry: 6/30/2015; Lot #: DM11856, Expiry: 6/30/2015; Lot #: DM12517, Expiry: 8/31/2015; Lot #: DM12519, Expiry: 8/31/2015; Lot #: DM12528, Expiry: 8/31/2015; Lot #: DM12529, Expiry: 8/31/2015; Lot #: DM12534, Expiry: 8/31/2015; Lot #: DM12535, Expiry: 8/31/2015. C) Lot #: DM11018, Expiry: 4/30/2015; Lot #: DM11019, Expiry: 4/30/2015; Lot #: DM11028, Expiry: 4/30/2015; Lot #: DM11029, Expiry: 4/30/2015; Lot #: DM11049, Expiry: 4/30/2015; Lot #: DM11050, Expiry: 4/30/2015; Lot #: DM11468, Expiry: 5/31/2015; Lot #: DM11469, Expiry: 5/31/2015; Lot #: DM11480, Expiry: 5/31/2015; Lot #: DM11483, Expiry: 5/31/2015; Lot #: DM12087, Expiry: 7/31/2015; Lot #: DM12095, Expiry: 7/31/2015; Lot #: DM12112, Expiry: 7/31/2015; Lot #: DM12129, Expiry: 7/31/2015; Lot #: DM12140, Expiry: 7/31/2015; Lot #: DM12141, Expiry: 7/31/2015; Lot #: DM12177, Expiry: 7/31/2015; Lot #: DM12499, Expiry: 8/31/2015; Lot #: DM12505, Expiry: 8/31/2015; Lot #: DM12509, Expiry: 8/31/2015; Lot #: DM12510, Expiry: 8/31/2015; Lot #: DM13306, Expiry: 11/30/2015; Lot #: DM13307, Expiry: 11/30/2015; Lot #: DM13313, Expiry: 11/30/2015; Lot #: DN10316, Expiry: 12/31/2015; Lot #: DN10332, Expiry: 12/31/2015; Lot #: DN10333, Expiry: 12/31/2015; Lot #: DN10348, Expiry: 12/31/2015; Lot #: DN10353, Expiry: 12/31/2015; Lot #: DN10369, Expiry: 12/31/2015; Lot #: DN10374, Expiry: 12/31/2015; Lot #: DN10375, Expiry: 12/31/2015; Lot #: DN10396, Expiry: 12/31/2015; Lot #: DN10854, Expiry: 2/29/2016; Lot #: DN10855, Expiry: 2/29/2016; Lot #: DN10872, 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-1261-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026