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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 # H001156 4/30/2022 [redacted-phone] H001627 5/31/2022 [redacted-phone] H001947 6/30/2022 [redacted-phone] H002242 8/31/2022 [redacted-phone] H101826 7/31/2023 [redacted-phone] H001155 4/30/2022 [redacted-phone] H001355 5/31/2022 [redacted-phone] H001356 5/31/2022 [redacted-phone] H001357 5/31/2022 [redacted-phone] H001358 5/31/2022 [redacted-phone] H001359 5/31/2022 [redacted-phone] H001371 5/31/2022 [redacted-phone] H001372 5/31/2022 [redacted-phone] H001373 5/31/2022 [redacted-phone] H001374 5/31/2022 [redacted-phone] H001375 5/31/2022 [redacted-phone] H001628 5/31/2022 [redacted-phone] H001629 5/31/2022 [redacted-phone] H001630 6/30/2022 [redacted-phone] H001645 6/30/2022 [redacted-phone] H001646 6/30/2022 [redacted-phone] H001647 6/30/2022 [redacted-phone] H001798 6/30/2022 [redacted-phone] H001799 6/30/2022 [redacted-phone] H001882 6/30/2022 [redacted-phone] H001883 6/30/2022 [redacted-phone] H001948 6/30/2022 [redacted-phone] H001949 6/30/2022 [redacted-phone] H001985 6/30/2022 [redacted-phone] H001986 6/30/2022 [redacted-phone] H001987 7/31/2022 [redacted-phone] H001988 7/31/2022 [redacted-phone] H001989 7/31/2022 [redacted-phone] H001990 7/31/2022 [redacted-phone] H002243 8/31/2022 [redacted-phone] H002244 8/31/2022 [redacted-phone] H002245 8/31/2022 [redacted-phone] H002315 8/31/2022 [redacted-phone] H002316 8/31/2022 [redacted-phone] H002317 8/31/2022 [redacted-phone] H002318 8/31/2022 [redacted-phone] H002319 8/31/2022 [redacted-phone] H002320 8/31/2022 [redacted-phone] H002321 8/31/2022 [redacted-phone] H002322 8/31/2022 [redacted-phone] H002323 8/31/2022 [redacted-phone] H002324 8/31/2022 [redacted-phone] H002632 9/30/2022 [redacted-phone] H002633 9/30/2022 [redacted-phone] H002634 9/30/2022 [redacted-phone] H002635 9/30/2022 [redacted-phone] H002636 9/30/2022 [redacted-phone] H002765 9/30/2022 [redacted-phone] H002766 9/30/2022 [redacted-phone] H002767 9/30/2022 [redacted-phone] H002768 9/30/2022 [redacted-phone] H002769 9/30/2022 [redacted-phone] H002770 9/30/2022 [redacted-phone] H003194 11/30/2022 [redacted-phone] H003195 11/30/2022 [redacted-phone] H100009 12/31/2022 [redacted-phone] H100010 12/31/2022 [redacted-phone] H100021 12/31/2022 [redacted-phone] H100022 12/31/2022 [redacted-phone] H100023 12/31/2022 [redacted-phone] H100029 12/31/2022 [redacted-phone] H100030 12/31/2022 [redacted-phone] H100342 1/31/2023 [redacted-phone] H100343 1/31/2023 [redacted-phone] H100344 1/31/2023 [redacted-phone] H100345 1/31/2023 [redacted-phone] H100346 1/31/2023 [redacted-phone] H100374 1/31/2023 [redacted-phone] H100375 1/31/2023 [redacted-phone] H100376 1/31/2023 [redacted-phone] H100377 1/31/2023 [redacted-phone] H100378 1/31/2023 [redacted-phone] H100452 1/31/2023 [redacted-phone] H100453 1/31/2023 [redacted-phone] H100454 2/28/2023 [redacted-phone] H100458 2/28/2023 [redacted-phone] H100459 2/28/2023 [redacted-phone] H100652 2/28/2023 [redacted-phone] H100653 2/28/2023 [redacted-phone] H100654 2/28/2023 [redacted-phone] H100655 2/28/2023 [redacted-phone] H100656 2/28/2023 [redacted-phone] H100687 2/28/2023 [redacted-phone] H100688 2/28/2023 [redacted-phone] H100689 2/28/2023 [redacted-phone] H100703 2/28/2023 [redacted-phone] H100704 2/28/2023 [redacted-phone] H100891 3/31/2023 [redacted-phone] H100892 3/31/2023 [redacted-phone] H100902 3/31/2023 [redacted-phone] H100903 3/31/2023 [redacted-phone] H100904 3/31/2023 [redacted-phone] H100905 3/31/2023 [redacted-phone] H100936 3/31/2023 [redacted-phone] H100937 3/31/2023 [redacted-phone] H100938 3/31/2023 [redacted-phone] H101153 5/31/2023 [redacted-phone] H101154 5/31/2023 [redacted-phone] H101155 5/31/2023 [redacted-phone] H101156 5/31/2023 [redacted-phone] H101157 5/31/2023 [redacted-phone] H101158 5/31/2023 [redacted-phone] H101159 5/31/2023 [redacted-phone] H101294 5/31/2023 [redacted-phone] H101295 5/31/2023 [redacted-phone] H101296 5/31/2023 [redacted-phone] H101297 5/31/2023 [redacted-phone] H101325 5/31/2023 [redacted-phone] H101326 6/30/2023 [redacted-phone] H101327 6/30/2023 [redacted-phone] H101328 6/30/2023 [redacted-phone] H101349 6/30/2023 [redacted-phone] H101350 6/30/2023 [redacted-phone] H101351 6/30/2023 [redacted-phone] H101352 6/30/2023 [redacted-phone] H101482 6/30/2023 [redacted-phone] H101483 6/30/2023 [redacted-phone] H101606 7/31/2023 [redacted-phone] H101618 7/31/2023 [redacted-phone] H101619 7/31/2023 [redacted-phone] H101620 7/31/2023 [redacted-phone] H101621 7/31/2023 [redacted-phone] H101827 7/31/2023 [redacted-phone] H101828 7/31/2023 [redacted-phone] H101829 7/31/2023 [redacted-phone] H101857 7/31/2023 [redacted-phone] H101858 7/31/2023 [redacted-phone] H101911 7/31/2023 [redacted-phone] H101912 7/31/2023 [redacted-phone] H101913 7/31/2023 [redacted-phone] H102455 10/31/2023 [redacted-phone] H102456 10/31/2023 [redacted-phone] H102457 10/31/2023 [redacted-phone] H102458 10/31/2023 [redacted-phone] H102485 10/31/2023 [redacted-phone] H102489 10/31/2023 [redacted-phone] H102490 10/31/2023 [redacted-phone] H102491 10/31/2023 [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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. 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 nameLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Generic nameLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Active ingredient(s)HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM
Distributed by / forLupin Pharmaceuticals Inc.
NDC68180-217-06
Show the full FDA record
Full product labelLosartan 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
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed nationwide
Quantity303,696 bottles
Recall initiated2022-03-31
Report date2022-05-11
Recall completed2023-05-22
Recall numberD-0842-2022
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

Losartan recallsHydrochlorothiazide recallsRecent drug recallsCheck another medication

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.