NDC 68180-979

Lisinopril 40 mg tablet

Where it's made

Factory	Where	Role	Last FDA inspection
Lupin Limited	Salcette, India	Makes it and packages it	Problems found, fixed voluntarilyNov 21, 2025 · 9 inspections, 1 with FDA action
Lupin Limited	Pithampur, India	Makes it and packages it	Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action
Lupin Limited	Nagpur, India	Makes it and packages it	Problems found, fixed voluntarilyJul 11, 2023 · 4 inspections

Sep 13, 2022 · Class II · Lupin Pharmaceuticals Inc.
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Lots: Lot # Q201182, exp. date March 2024
May 28, 2020 · Class II · Lupin Pharmaceuticals Inc.
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Lots: Lot # Q900683, Exp. 10/31/2022
Apr 1, 2020 · Class II · Lupin Pharmaceuticals Inc.
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
Lots: Lot #: Q900580, Exp 9/2021
Aug 13, 2018 · Class II · Lupin Pharmaceuticals Inc.
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Lots: Lot #: H800414, Exp. 12/2019
Apr 6, 2016 · Class III · Lupin Pharmaceuticals Inc.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lots: Batch number: H303487, H303488, H303489, Exp 09/16
Apr 6, 2016 · Class III · Lupin Pharmaceuticals Inc.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lots: Batch number: H303449, Exp 09/16

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Lisinopril: every company that makes it
Form: tablet, oral
Strength: 40 mg
Approval: ANDA ANDA077321
On the market since: Jun 1, 2021
Package NDCs: 68180-979-01 68180-979-03 68180-979-09 68180-979-30
Official label: DailyMed (National Library of Medicine), updated Oct 10, 2025

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