NDC 68645-525
Losartan Potassium 50 mg tablet
On the label: Legacy Pharmaceutical Packaging. It's repackaged: Legacy Pharmaceutical Packaging rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-308.
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 |
Recalls
- Mar 31, 2022 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: H001333, exp. date Nov-22 H002786, exp. date Jan-23 H101282, exp. date Feb-23 H001189, exp. date Nov-22 H002955, exp. date Jan-23 H101285, exp. date Feb-23 H001714, exp. date Dec-22 H000523, exp. date Jan-23 H101989, exp. date Mar-23 H001940, exp. date Dec-22 H003080, exp. date Jan-23 H1… - Mar 31, 2022 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: H903720, exp. date Oct-22 H001876, exp. date Dec-22 H003002, exp. date Jan-23 H903774, exp. date Oct-22 H001877, exp. date Dec-22 H003003, exp. date Feb-23 H000849, exp. date Nov-22 H002127, exp. date Dec-22 H003004, exp. date Feb-23 H001412, exp. date Nov-22 H002128, exp. date Dec-22 H0… - Mar 31, 2022 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lots: H903573, exp. date Oct-22 H002311, exp. date Dec-22 H100713, exp. date Mar-23 H001060, exp. date Nov-22 H002620, exp. date Jan-23 H100714, exp. date Mar-23 H001456, exp. date Nov-22 H002313, exp. date Jan-23 H100934, exp. date Mar-23 H001457, exp. date Nov-22 H002490, exp. date Jan-23 H1…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Losartan: every company that makes it
- Form
- tablet
- Strength
- 50 mg
- Approval
- ANDA ANDA078232
- On the market since
- Oct 6, 2010
- Package NDCs
68645-525-70- Official label
- DailyMed (National Library of Medicine), updated Apr 25, 2016
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