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Losartan and Hydrochlorothiazide Tablets Shortage

Last Updated: April 4, 2024
Status: Current

Products Affected - Description
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 12.5 mg, bottle, 30 count, NDC 59746-0338-30 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 25 mg, bottle, 30 count, NDC 59746-0339-30 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 25 mg, bottle, 90 count, NDC 59746-0338-90 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 100 mg/ 25 mg, bottle, 90 count, NDC 59746-0339-90 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 50 mg/ 12.5 mg, bottle, 90 count, NDC 59746-0337-90 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Cadista, 50 mg/ 12.5 mg, bottle, 90 count, NDC 59746-0337-30 - discontinued
    • 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 00781-5207-92 - 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, 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 00093-7369-56
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 12.5 mg, bottle, 90 count, NDC 00093-7369-98
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 00093-7369-10
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 25 mg, bottle, 30 count, NDC 00093-7368-56
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 25 mg, bottle, 90 count, NDC 00093-7368-98
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 100 mg/ 25 mg, bottle, 1000 count, NDC 00093-7368-10
    • Losartan and Hydrochlorothiazide oral tablet, Teva, 50 mg/ 12.5 mg, bottle, 30 count, NDC 00093-7367-56
    • 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
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 12.5 mg, bottle, 30 count, NDC 13668-0117-30 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 12.5 mg, bottle, 90 count, NDC 13668-0117-90 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 12.5 mg, bottle, 1000 count, NDC 13668-0117-10 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 25 mg, bottle, 30 count, NDC 13668-0118-30 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 25 mg, bottle, 90 count, NDC 13668-0118-90 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 100 mg/ 25 mg, bottle, 1000 count, NDC 13668-0118-10 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 30 count, NDC 13668-0116-30 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 90 count, NDC 13668-0116-90 - discontinued
    • Losartan and Hydrochlorothiazide oral tablet, Torrent, 50 mg/ 12.5 mg, bottle, 1000 count, NDC 13668-0116-10 - discontinued
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 is not currently marketing the 30 count and 1,000 count presentations. The 90 count bottles are available to contracted customers.
    • Aurobindo refuses to provide updated availability information
    • Cadista has discontinued losartan and hydrochlorothiazide tablets.
    • Lupin has losartan and hydrochlorothiazide tablets available.
    • Organon has Hyzaar available.
    • Teva states the shortage is due to a delay in obtaining active ingredient.
Available Products
    • Hyzaar oral tablet, Organon, 100 mg/ 12.5 mg, bottle, 30 count, NDC 78206-0140-01
    • Hyzaar oral tablet, Organon, 100 mg/ 12.5 mg, bottle, 90 count, NDC 78206-0140-02
    • Hyzaar oral tablet, Organon, 100 mg/ 25 mg, bottle, 30 count, NDC 78206-0141-01
    • Hyzaar oral tablet, Organon, 100 mg/ 25 mg, bottle, 90 count, NDC 78206-0141-02
    • Hyzaar oral tablet, Organon, 50 mg /12.5 mg, bottle, 30 count, NDC 78206-0139-01
    • Hyzaar oral tablet, Organon, 50 mg /12.5 mg, bottle, 90 count, NDC 78206-0139-02
    • 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/ 25 mg, bottle, 90 count, NDC 62332-0050-90
    • Losartan and Hydrochlorothiazide oral tablet, Alembic, 50 mg/ 12.5 mg, bottle, 90 count, NDC 62332-0048-90
    • 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

Estimated Resupply Dates

    • Teva has all losartan and hydrochlorothiazide tablet presentations on back order and the company cannot estimate a release date.

Updated

Updated April 4, 2024 by Leslie Jensen, PharmD, Drug Information Specialist. Created February 11, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

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