NDC 53808-0451
Lisinopril and hydrochlorothiazide 5 mg / 12.5 mg tablet
On the label: State of Florida DOH Central Pharmacy. It's repackaged: State of Florida DOH Central Pharmacy rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-513.
Where the pills inside were 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 |
Recalls
- 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.
Product details
- Generic drug
- Hydrochlorothiazide and Lisinopril: every company that makes it
- Form
- tablet
- Strength
- 5 mg / 12.5 mg
- Approval
- ANDA ANDA077321
- On the market since
- Jul 1, 2009
- Package NDCs
53808-0451-1- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2010
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