NDC 53002-2178

Lisinopril 20 mg tablet

On the label: RPK Pharmaceuticals, Inc.. It's a repackaged product: RPK Pharmaceuticals, Inc. rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-981.

Where the pills inside were made

Salcette, India · makes it and packages it

Problems found, fixed voluntarily Last FDA inspection Nov 21, 2025. 9 inspections on record, 1 with serious problems.

Pithampur, India · makes it and packages it

Serious problems, FDA action Last FDA inspection Jul 17, 2025. 6 inspections on record, 4 with serious problems.

Nagpur, India · makes it and packages it

Problems found, fixed voluntarily Last FDA inspection Jul 11, 2023. 4 inspections on record.

Sep 13, 2022 · Class II · Terminated
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Lots: Lot # Q201182, exp. date March 2024
May 28, 2020 · Class II · Terminated
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 · Terminated
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 · Terminated
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 · Terminated
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 · Terminated
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lots: Batch number: H303449, Exp 09/16

Generic drug: Lisinopril: see every company that makes it
Form: tablet
Strength: 20 mg
Approval: ANDA ANDA077321
On the market since: May 12, 2017
Package NDCs: 53002-2178-0 53002-2178-3 53002-2178-6
Official label: DailyMed (National Library of Medicine), updated Sep 11, 2023

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