Lupin Limited
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.
NDC 68180-752
Amlodipine Besylate 10 mg tablet
On the label: Lupin Pharmaceuticals, Inc..
Where it's made
Lupin Limited
Chhatrapati Sambhajinagar, India · makes it and packages it
Problems found, fixed voluntarily Last FDA inspection Mar 15, 2024. 5 inspections on record.
Recalls
- Jun 27, 2023 · Class III · Terminated
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Lots: Lot #: A102887, Exp. 6/2023 - Feb 19, 2016 · Class III · Terminated
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lots: Lot #: G304799, Exp. 4/2016 - Feb 19, 2016 · Class III · Terminated
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lots: Lot #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016
Product details
- Generic drug
- Amlodipine: see every company that makes it
- Form
- tablet
- Strength
- 10 mg
- Approval
- ANDA ANDA078043
- On the market since
- Aug 3, 2007
- Package NDCs
68180-752-0368180-752-09- Official label
- DailyMed (National Library of Medicine), updated Apr 20, 2026
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?