RecallRadar

FDA Drug recall D-1257-2015

Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C)…

On 2015-07-29 the FDA classified a Class II recall of Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C)… by Wockhardt Usa, citing CGMP Deviations: Firm did not adequately investigate customer complaints.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1257-2015
ClassificationClass II
Statusterminated
Initiated2015-04-22
Published2015-07-29
Last updated2026-09-13 11:51 UTC
CompanyWockhardt Usa
DistributionUS

Product

Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), 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 #: DM10991, Expiry: 4/30/2015; Lot #: DM11226, Expiry: 4/30/2015; Lot #: DM11665, Expiry: 6/30/2015; Lot #: DM11…A) Lot #: DM10991, Expiry: 4/30/2015; Lot #: DM11226, Expiry: 4/30/2015; Lot #: DM11665, Expiry: 6/30/2015; Lot #: DM11810, Expiry: 6/30/2015; Lot #: DM12702, Expiry: 9/30/2015; Lot #: DN10719, Expiry: 1/31/2016. B) Lot #: DM11651, Expiry: 6/30/2015; Lot #: DM11652, Expiry: 6/30/2015; Lot #: DM11664, Expiry: 6/30/2015; Lot #: DM12701, Expiry: 9/30/2015; Lot #: DN10139, Expiry: 12/31/2015. C) Lot #: DM11041, Expiry: 4/30/2015; Lot #: DM11267, Expiry: 4/30/2015; Lot #: DM11268, Expiry: 4/30/2015; Lot #: DM11279, Expiry: 5/31/2015; Lot #: DM11286, Expiry: 5/31/2015; Lot #: DM11292, Expiry: 5/31/2015; Lot #: DM11625, Expiry: 6/30/2015; Lot #: DM11626, Expiry: 6/30/2015; Lot #: DM11670, Expiry: 6/30/2015; Lot #: DM11772, Expiry: 6/30/2015; Lot #: DM11773, Expiry: 6/30/2015; Lot #: DM11809, Expiry: 6/30/2015; Lot #: DM12698, Expiry: 9/30/2015; Lot #: DN10110, Expiry: 11/30/2015; Lot #: DN10608, Expiry: 1/31/2016; Lot #: DN10642, Expiry: 1/31/2016; Lot #: DN10694, Expiry: 1/31/2016; Lot #: D

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-1257-2015%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.