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Losartan and Hydrochlorothiazide Tablets Shortage

Last Updated: December 18, 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, 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, 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
    • 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, 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, 1000 count, NDC 00093-7367-10

Estimated Resupply Dates

    • Teva has losartan and hydrochlorothiazide 50 mg/12.5 mg tablets in 90 count bottles and 100 mg/12.5 mg tablets in 90 count bottles on intermittent back order and the company is releasing supplies as they become available.

Updated

Updated December 18, 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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