RecallRadar

FDA Drug recall D-1346-2015

Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India

On 2015-08-26 the FDA classified a Class II recall of Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India by Wockhardt Usa, citing CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1346-2015
ClassificationClass II
Statusterminated
Initiated2015-07-29
Published2015-08-26
Last updated2026-09-13 11:51 UTC
CompanyWockhardt Usa
DistributionUS

Product

Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.

Reason

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Identifiers

upc364679928066
code_infoLot #: DM12700, Exp 09/15

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-1346-2015%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.