Losartan/Hydrochlorothiazide 100/25mg (Lupin) – AZIDO Impurity Excess (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Lupin Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Lupin Pharmaceuticals Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 6818 due to CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026