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5/14/2020

Losartan and Hydrochlorothiazide Tablets

Products Affected - Description

    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 12.5 mg, bottle, 30 count, NDC 62332-0049-30
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 12.5 mg, bottle, 90 count, NDC 62332-0049-90
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 62332-0049-91
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 25 mg, bottle, 30 count, NDC 62332-0050-30
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 25 mg, bottle, 90 count, NDC 62332-0050-90
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 100 mg/ 25 mg, bottle, 1000 count, NDC 62332-0050-91
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 50 mg/ 12.5 mg, bottle, 30 count, NDC 62332-0048-30
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 50 mg/ 12.5 mg, bottle, 90 count, NDC 62332-0048-90
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 62332-0048-91
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 12.5 mg, bottle, 30 count, NDC 59746-0338-30
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 25 mg, bottle, 30 count, NDC 59746-0339-30
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 25 mg, bottle, 90 count, NDC 59746-0338-90
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 25 mg, bottle, 90 count, NDC 59746-0339-90
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 50 mg/ 12.5 mg, bottle, 90 count, NDC 59746-0337-90
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 50 mg/ 12.5 mg, bottle, 90 count, NDC 59746-0337-30
    • Losartan and Hydrochlorothiazide oral tablet, Lupin, 100 mg/ 12.5 mg, bottle, 30 count, NDC 68180-0216-06
    • Losartan and Hydrochlorothiazide oral tablet, Lupin, 100 mg/ 12.5 mg, bottle, 90 count, NDC 68180-0216-09
    • Losartan and Hydrochlorothiazide oral tablet, Lupin, 100 mg/ 25 mg, bottle, 30 count, NDC 68180-0217-06
    • Losartan and Hydrochlorothiazide oral tablet, Lupin, 100 mg/ 25 mg, bottle, 90 count, NDC 68180-0217-09
    • Losartan and Hydrochlorothiazide oral tablet, Lupin, 50 mg/ 12.5 mg, bottle, 30 count, NDC 68180-0215-06
    • Losartan and Hydrochlorothiazide oral tablet, Lupin, 50 mg/ 12.5 mg, bottle, 90 count, NDC 68180-0215-09
    • Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 100 mg/ 12.5 mg, bottle, 90 count, NDC 57237-0208-90 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 57237-0208-99 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 100 mg/ 25 mg, bottle, 1000 count, NDC 57237-0209-99 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 50 mg/ 12.5 mg, bottle, 90 count, NDC 57237-0207-90 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Rising Pharmaceuticals, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 57237-0207-99 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 12.5 mg, bottle, 30 count, NDC 00781-5204-31 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00781-5204-92 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00781-5207-92 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 00781-5204-10 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 25 mg, bottle, 30 count, NDC 00781-5207-31 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 100 mg/ 25 mg, bottle, 1000 count, NDC 00781-5207-10 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 50 mg/ 12.5 mg, bottle, 30 count, NDC 00781-5206-31 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 50 mg/ 12.5 mg, bottle, 90 count, NDC 00781-5206-92 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Sandoz, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 00781-5206-10 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 12.5 mg, bottle, 30 count, NDC 00093-7368-56
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00093-7368-98
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 25 mg, bottle, 30 count, NDC 00093-7369-56
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 25 mg, bottle, 90 count, NDC 00093-7369-98
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 50 mg/ 12.5 mg, bottle, 90 count, NDC 00093-7367-98
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 00093-7367-10

Reason for the Shortage

    • Beginning in mid-2018, FDA found that several angiotensin II receptor blocker (ARB) medicines contained nitrosamine impurities and have been recalled because they do not meet FDA's safety standards. Additional information including a list of affected lots can be found at https://www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and-irbesartan.
    • Alembic did not provide a reason for the shortage.
    • Aurobindo refused to provide updated availability information
    • Cadista did not provide a reason for the shortage.
    • Lupin did not provide a reason for the shortage.
    • Merck has Hyzaar available.
    • Rising discontinued all losartan and hydrochlorothiazide presentations.
    • Sandoz recalled one lot of losartan and hydrochlorothiazide 100 mg/25 mg tablets in 1000 count bottles in November 2018 due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm625492.htm.
    • Sandoz discontinued all losartan and hydrochlorothiazide presentations.
    • Torrent recalled several lots of losartan and hydrochlorothiazide tablet presentations due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium.
    • Torrent has losartan and hydrochlorothiazide tablets available in all presentations (from lots unaffected by the recall).
    • Teva did not provide a reason for the shortage.

Available Products

    • Hyzaar oral tablet, Merck, 100 mg/ 12.5 mg, bottle, 30 count, NDC 00006-0745-31
    • Hyzaar oral tablet, Merck, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00006-0745-54
    • Hyzaar oral tablet, Merck, 100 mg/ 25 mg, bottle, 30 count, NDC 00006-0747-31
    • Hyzaar oral tablet, Merck, 100 mg/ 25 mg, bottle, 90 count, NDC 00006-0747-54
    • Hyzaar oral tablet, Merck, 50 mg /12.5 mg, bottle, 30 count, NDC 00006-0717-31
    • Hyzaar oral tablet, Merck, 50 mg/ 12.5 mg, bottle, 90 count, NDC 00006-0717-54
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 00093-7368-10
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 25 mg, bottle, 1000 count, NDC 00093-7369-10
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 50 mg/ 12.5 mg, bottle, 30 count, NDC 00093-7367-56
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 12.5 mg, bottle, 30 count, NDC 13668-0117-30
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 12.5 mg, bottle, 90 count, NDC 13668-0117-90
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 13668-0117-10
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 25 mg, bottle, 30 count, NDC 13668-0118-30
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 25 mg, bottle, 90 count, NDC 13668-0118-90
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 25 mg, bottle, 1000 count, NDC 13668-0118-10
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 30 count, NDC 13668-0116-30
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 90 count, NDC 13668-0116-90
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 13668-0116-10

Estimated Resupply Dates

    • Alembic has losartan and hydrochlorothiazide tablets on allocation to contracted customers
    • Cadista has losartan and hydrochlorothiazide tablets on allocation.
    • Lupin has losartan and hydrochlorothiazide tablets on back order and the company cannot estimate a release date.
    • Teva has losartan and hydrochlorothiazide presentations on intermittent back order and the company is releasing product as it becomes available.

Updated

Updated May 14, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. Created February 11, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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