Recall archive / FDA drug enforcement
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-co... — FDA record D-0842-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 31, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 303,696 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0842-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # H001156 4/30/2022 68180-217-06 H001627 5/31/2022 68180-217-06 H001947 6/30/2022 68180-217-06 H002242 8/31/2022 68180-217-06 H101826 7/31/2023 68180-217-06 H001155 4/30/2022 68180-217-09 H001355 5/31/2022 68180-217-09 H001356 5/31/2022 68180-217-09 H001357 5/31/2022 68180-217-09 H001358 5/31/2022 68180-217-09 H001359 5/31/2022 68180-217-09 H001371 5/31/2022 68180-217-09 H001372 5/31/2022 68180-217-09 H001373 5/31/2022 68180-217-09 H001374 5/31/2022 68180-217-09 H001375 5/31/2022 68180-217-09 H001628 5/31/2022 68180-217-09 H001629 5/31/2022 68180-217-09 H001630 6/30/2022 68180-217-09 H001645 6/30/2022 68180-217-09 H001646 6/30/2022 68180-217-09 H001647 6/30/2022 68180-217-09 H001798 6/30/2022 68180-217-09 H001799 6/30/2022 68180-217-09 H001882 6/30/2022 68180-217-09 H001883 6/30/2022 68180-217-09 H001948 6/30/2022 68180-217-09 H001949 6/30/2022 68180-217-09 H001985 6/30/2022 68180-217-09 H001986 6/30/2022 68180-217-09 H001987 7/31/2022 68180-217-09 H001988 7/31/2022 68180-217-09 H001989 7/31/2022 68180-217-09 H001990 7/31/2022 68180-217-09 H002243 8/31/2022 68180-217-09 H002244 8/31/2022 68180-217-09 H002245 8/31/2022 68180-217-09 H002315 8/31/2022 68180-217-09 H002316 8/31/2022 68180-217-09 H002317 8/31/2022 68180-217-09 H002318 8/31/2022 68180-217-09 H002319 8/31/2022 68180-217-09 H002320 8/31/2022 68180-217-09 H002321 8/31/2022 68180-217-09 H002322 8/31/2022 68180-217-09 H002323 8/31/2022 68180-217-09 H002324 8/31/2022 68180-217-09 H002632 9/30/2022 68180-217-09 H002633 9/30/2022 68180-217-09 H002634 9/30/2022 68180-217-09 H002635 9/30/2022 68180-217-09 H002636 9/30/2022 68180-217-09 H002765 9/30/2022 68180-217-09 H002766 9/30/2022 68180-217-09 H002767 9/30/2022 68180-217-09 H002768 9/30/2022 68180-217-09 H002769 9/30/2022 68180-217-09 H002770 9/30/2022 68180-217-09 H003194 11/30/2022 68180-217-09 H003195 11/30/2022 68180-217-09 H100009 12/31/2022 68180-217-09 H100010 12/31/2022 68180-217-09 H100021 12/31/2022 68180-217-09 H100022 12/31/2022 68180-217-09 H100023 12/31/2022 68180-217-09 H100029 12/31/2022 68180-217-09 H100030 12/31/2022 68180-217-09 H100342 1/31/2023 68180-217-09 H100343 1/31/2023 68180-217-09 H100344 1/31/2023 68180-217-09 H100345 1/31/2023 68180-217-09 H100346 1/31/2023 68180-217-09 H100374 1/31/2023 68180-217-09 H100375 1/31/2023 68180-217-09 H100376 1/31/2023 68180-217-09 H100377 1/31/2023 68180-217-09 H100378 1/31/2023 68180-217-09 H100452 1/31/2023 68180-217-09 H100453 1/31/2023 68180-217-09 H100454 2/28/2023 68180-217-09 H100458 2/28/2023 68180-217-09 H100459 2/28/2023 68180-217-09 H100652 2/28/2023 68180-217-09 H100653 2/28/2023 68180-217-09 H100654 2/28/2023 68180-217-09 H100655 2/28/2023 68180-217-09 H100656 2/28/2023 68180-217-09 H100687 2/28/2023 68180-217-09 H100688 2/28/2023 68180-217-09 H100689 2/28/2023 68180-217-09 H100703 2/28/2023 68180-217-09 H100704 2/28/2023 68180-217-09 H100891 3/31/2023 68180-217-09 H100892 3/31/2023 68180-217-09 H100902 3/31/2023 68180-217-09 H100903 3/31/2023 68180-217-09 H100904 3/31/2023 68180-217-09 H100905 3/31/2023 68180-217-09 H100936 3/31/2023 68180-217-09 H100937 3/31/2023 68180-217-09 H100938 3/31/2023 68180-217-09 H101153 5/31/2023 68180-217-09 H101154 5/31/2023 68180-217-09 H101155 5/31/2023 68180-217-09 H101156 5/31/2023 68180-217-09 H101157 5/31/2023 68180-217-09 H101158 5/31/2023 68180-217-09 H101159 5/31/2023 68180-217-09 H101294 5/31/2023 68180-217-09 H101295 5/31/2023 68180-217-09 H101296 5/31/2023 68180-217-09 H101297 5/31/2023 68180-217-09 H101325 5/31/2023 68180-217-09 H101326 6/30/2023 68180-217-09 H101327 6/30/2023 68180-217-09 H101328 6/30/2023 68180-217-09 H101349 6/30/2023 68180-217-09 H101350 6/30/2023 68180-217-09 H101351 6/30/2023 68180-217-09 H101352 6/30/2023 68180-217-09 H101482 6/30/2023 68180-217-09 H101483 6/30/2023 68180-217-09 H101606 7/31/2023 68180-217-09 H101618 7/31/2023 68180-217-09 H101619 7/31/2023 68180-217-09 H101620 7/31/2023 68180-217-09 H101621 7/31/2023 68180-217-09 H101827 7/31/2023 68180-217-09 H101828 7/31/2023 68180-217-09 H101829 7/31/2023 68180-217-09 H101857 7/31/2023 68180-217-09 H101858 7/31/2023 68180-217-09 H101911 7/31/2023 68180-217-09 H101912 7/31/2023 68180-217-09 H101913 7/31/2023 68180-217-09 H102455 10/31/2023 68180-217-09 H102456 10/31/2023 68180-217-09 H102457 10/31/2023 68180-217-09 H102458 10/31/2023 68180-217-09 H102485 10/31/2023 68180-217-09 H102489 10/31/2023 68180-217-09 H102490 10/31/2023 68180-217-09 H102491 10/31/2023 68180-217-09 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed nationwide
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 11, 2022
- Recall initiation date
- Mar 31, 2022
- Center classification date
- May 3, 2022
- Termination date
- May 22, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.