Class II · ModerateRecall completed
Losartan Potassium And Hydrochlorothiazide
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # H001149 4/30/2022 [redacted-phone] H001602 5/31/2022 [redacted-phone] H001884 6/30/2022 [redacted-phone] H002539 8/31/2022 [redacted-phone] H100944 4/30/2023 [redacted-phone] H101054 4/30/2023 [redacted-phone] H001150 4/30/2022 [redacted-phone] H001151 4/30/2022 [redacted-phone] H001152 4/30/2022 [redacted-phone] H001532 5/31/2022 [redacted-phone] H001533 5/31/2022 [redacted-phone] H001534 5/31/2022 [redacted-phone] H001535 5/31/2022 [redacted-phone] H001536 5/31/2022 [redacted-phone] H001603 5/31/2022 [redacted-phone] H001604 5/31/2022 [redacted-phone] H001605 5/31/2022 [redacted-phone] H001606 5/31/2022 [redacted-phone] H001607 5/31/2022 [redacted-phone] H001608 5/31/2022 [redacted-phone] H001885 6/30/2022 [redacted-phone] H001886 6/30/2022 [redacted-phone] H001887 6/30/2022 [redacted-phone] H001888 6/30/2022 [redacted-phone] H002171 7/31/2022 [redacted-phone] H002172 7/31/2022 [redacted-phone] H002173 7/31/2022 [redacted-phone] H002174 7/31/2022 [redacted-phone] H002175 7/31/2022 [redacted-phone] H002540 8/31/2022 [redacted-phone] H002541 8/31/2022 [redacted-phone] H002542 8/31/2022 [redacted-phone] H002543 8/31/2022 [redacted-phone] H002544 8/31/2022 [redacted-phone] H002545 8/31/2022 [redacted-phone] H002976 10/31/2022 [redacted-phone] H002977 10/31/2022 [redacted-phone] H002978 10/31/2022 [redacted-phone] H003131 11/30/2022 [redacted-phone] H003132 11/30/2022 [redacted-phone] H003133 11/30/2022 [redacted-phone] H003134 11/30/2022 [redacted-phone] H003135 11/30/2022 [redacted-phone] H003136 11/30/2022 [redacted-phone] H100302 1/31/2023 [redacted-phone] H100303 1/31/2023 [redacted-phone] H100304 1/31/2023 [redacted-phone] H100340 1/31/2023 [redacted-phone] H100341 1/31/2023 [redacted-phone] H100657 2/28/2023 [redacted-phone] H100658 2/28/2023 [redacted-phone] H100659 2/28/2023 [redacted-phone] H100660 2/28/2023 [redacted-phone] H100661 2/28/2023 [redacted-phone] H100662 2/28/2023 [redacted-phone] H100945 4/30/2023 [redacted-phone] H100946 4/30/2023 [redacted-phone] H101051 4/30/2023 [redacted-phone] H101052 4/30/2023 [redacted-phone] H101053 4/30/2023 [redacted-phone] H101055 4/30/2023 [redacted-phone] H101056 4/30/2023 [redacted-phone] H101057 4/30/2023 [redacted-phone] H101058 4/30/2023 [redacted-phone] H101286 5/31/2023 [redacted-phone] H101287 5/31/2023 [redacted-phone] H101288 5/31/2023 [redacted-phone] H101289 5/31/2023 [redacted-phone] H101581 6/30/2023 [redacted-phone] H101582 6/30/2023 [redacted-phone] H101583 6/30/2023 [redacted-phone] H101584 7/31/2023 [redacted-phone] H101585 7/31/2023 [redacted-phone] H101790 7/31/2023 [redacted-phone] H101791 7/31/2023 [redacted-phone] H102078 8/31/2023 [redacted-phone] H102079 8/31/2023 [redacted-phone] H102080 9/30/2023 [redacted-phone] H102118 9/30/2023 [redacted-phone] H102119 9/30/2023 [redacted-phone] H102120 9/30/2023 [redacted-phone] H102125 9/30/2023 [redacted-phone] H102126 9/30/2023 [redacted-phone]
Where it was soldProduct was distributed nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byLupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA foreign manufacturer
| Brand name | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
| Generic name | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE |
| Active ingredient(s) | HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM |
| Distributed by / for | Lupin Pharmaceuticals Inc. |
| NDC | 68180-215-06 |
Show the full FDA record
| Full product label | Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Distribution | Product was distributed nationwide |
| Quantity | 1,214,016 bottles |
| Recall initiated | 2022-03-31 |
| Report date | 2022-05-11 |
| Recall completed | 2023-05-22 |
| Recall number | D-0841-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Baltimore MD United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.