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 # H001878 6/30/2022 [redacted-phone] H002178 7/31/2022 [redacted-phone] H002626 9/30/2022 [redacted-phone] H102149 9/30/2023 [redacted-phone] H001600 5/31/2022 [redacted-phone] H001601 5/1/2022 [redacted-phone] H001625 5/31/2022 [redacted-phone] H001626 5/31/2022 [redacted-phone] H001794 6/30/2022 [redacted-phone] H001795 6/30/2022 [redacted-phone] H001796 6/30/2022 [redacted-phone] H001797 6/30/2022 [redacted-phone] H001879 6/30/2022 [redacted-phone] H001880 6/30/2022 [redacted-phone] H001881 6/30/2022 [redacted-phone] H001942 6/30/2022 [redacted-phone] H001943 6/30/2022 [redacted-phone] H001944 6/30/2022 [redacted-phone] H001945 6/30/2022 [redacted-phone] H001946 6/30/2022 [redacted-phone] H002179 7/31/2022 [redacted-phone] H002180 7/31/2022 [redacted-phone] H002181 8/31/2022 [redacted-phone] H002182 8/31/2022 [redacted-phone] H002183 8/31/2022 [redacted-phone] H002237 8/31/2022 [redacted-phone] H002238 8/31/2022 [redacted-phone] H002239 8/31/2022 [redacted-phone] H002240 8/31/2022 [redacted-phone] H002241 8/31/2022 [redacted-phone] H002627 9/30/2022 [redacted-phone] H002628 9/30/2022 [redacted-phone] H002629 9/30/2022 [redacted-phone] H002630 9/30/2022 [redacted-phone] H002631 9/30/2022 [redacted-phone] H002979 11/30/2022 [redacted-phone] H002980 11/30/2022 [redacted-phone] H002981 11/30/2022 [redacted-phone] H002982 11/30/2022 [redacted-phone] H002983 11/30/2022 [redacted-phone] H100112 12/31/2022 [redacted-phone] H100113 12/31/2022 [redacted-phone] H100114 12/31/2022 [redacted-phone] H100115 12/31/2022 [redacted-phone] H100116 12/31/2022 [redacted-phone] H100156 12/31/2022 [redacted-phone] H100157 12/31/2022 [redacted-phone] H100622 2/28/2023 [redacted-phone] H100623 2/28/2023 [redacted-phone] H100624 2/28/2023 [redacted-phone] H100625 2/28/2023 [redacted-phone] H100626 2/28/2023 [redacted-phone] H100627 2/28/2023 [redacted-phone] H100628 2/28/2023 [redacted-phone] H100629 2/28/2023 [redacted-phone] H100939 4/30/2023 [redacted-phone] H100940 4/30/2023 [redacted-phone] H100941 4/30/2023 [redacted-phone] H100942 4/30/2023 [redacted-phone] H100943 4/30/2023 [redacted-phone] H101094 5/31/2023 [redacted-phone] H101095 5/31/2023 [redacted-phone] H101096 5/31/2023 [redacted-phone] H101097 5/31/2023 [redacted-phone] H101098 5/31/2023 [redacted-phone] H101151 5/31/2023 [redacted-phone] H101152 5/31/2023 [redacted-phone] H101290 5/31/2023 [redacted-phone] H101291 5/31/2023 [redacted-phone] H101292 5/31/2023 [redacted-phone] H101293 5/31/2023 [redacted-phone] H101323 5/31/2023 [redacted-phone] H101324 5/31/2023 [redacted-phone] H101823 7/31/2023 [redacted-phone] H101824 7/31/2023 [redacted-phone] H101825 7/31/2023 [redacted-phone] H101853 8/31/2023 [redacted-phone] H101854 8/31/2023 [redacted-phone] H101855 8/31/2023 [redacted-phone] H101856 8/31/2023 [redacted-phone] H102127 9/30/2023 [redacted-phone] H102128 9/30/2023 [redacted-phone] H102129 9/30/2023 [redacted-phone] H102130 9/30/2023 [redacted-phone] H102150 9/30/2023 [redacted-phone] H102151 9/30/2023 [redacted-phone] H102152 9/30/2023 [redacted-phone] H102153 9/30/2023 [redacted-phone] H102154 9/30/2023 [redacted-phone] H102155 9/30/2023 [redacted-phone] H102201 9/30/2023 [redacted-phone] H102223 9/30/2023 [redacted-phone] H102268 9/30/2023 [redacted-phone] H102269 9/30/2023 [redacted-phone] H102270 9/30/2023 [redacted-phone] H102271 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 | 68180-216-06 |
Show the full FDA record
| Full product label | Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), 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 | 2,361,924 bottles |
| Recall initiated | 2022-03-31 |
| Report date | 2022-05-11 |
| Recall completed | 2023-05-22 |
| Recall number | D-0843-2022 |
| 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.