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12/23/2019

Losartan Tablets

Products Affected - Description

    • Losartan potassium oral tablet, Alembic, 100 mg, bottle, 30 count, NDC 62332-0029-30
    • Losartan potassium oral tablet, Alembic, 100 mg, bottle, 90 count, NDC 62332-0029-90
    • Losartan potassium oral tablet, Alembic, 100 mg, bottle, 1000 count, NDC 62332-0029-91
    • Losartan potassium oral tablet, Alembic, 25 mg, bottle, 1000 count, NDC 62332-0027-91
    • Losartan potassium oral tablet, Alembic, 50 mg, bottle, 30 count, NDC 62332-0028-30
    • Losartan potassium oral tablet, Alembic, 50 mg, bottle, 90 count, NDC 62332-0028-90
    • Losartan potassium oral tablet, Alembic, 50 mg, bottle, 1000 count, NDC 62332-0028-91
    • Losartan potassium oral tablet, Avet Pharmaceuticals, 100 mg, bottle, 30 count, NDC 23155-0646-03
    • Losartan potassium oral tablet, Avet Pharmaceuticals, 100 mg, bottle, 90 count, NDC 23155-0646-09
    • Losartan potassium oral tablet, Avet Pharmaceuticals, 100 mg, bottle, 1000 count, NDC 23155-0646-10
    • Losartan potassium oral tablet, Avet Pharmaceuticals, 25 mg, bottle, 30 count, NDC 23155-0644-03
    • Losartan potassium oral tablet, Avet Pharmaceuticals, 25 mg, bottle, 90 count, NDC 23155-0644-09
    • Losartan potassium oral tablet, Avet Pharmaceuticals, 25 mg, bottle, 1000 count, NDC 23155-0644-10
    • Losartan potassium oral tablet, Avet Pharmaceuticals, 50 mg, bottle, 30 count, NDC 23155-0645-03
    • Losartan potassium oral tablet, Avet Pharmaceuticals, 50 mg, bottle, 90 count, NDC 23155-0645-09
    • Losartan potassium oral tablet, Avet Pharmaceuticals, 50 mg, bottle, 1000 count, NDC 23155-0645-10
    • Losartan potassium oral tablet, Cadista, 100 mg, bottle, 30 count, NDC 59746-0335-30
    • Losartan potassium oral tablet, Cadista, 100 mg, bottle, 90 count, NDC 59746-0335-90
    • Losartan potassium oral tablet, Cadista, 100 mg, bottle, 1000 count, NDC 59746-0335-10
    • Losartan potassium oral tablet, Cadista, 25 mg, bottle, 90 count, NDC 59746-0333-90
    • Losartan potassium oral tablet, Cadista, 25 mg, bottle, 1000 count, NDC 59746-0333-10
    • Losartan potassium oral tablet, Cadista, 50 mg, bottle, 30 count, NDC 59746-0334-30
    • Losartan potassium oral tablet, Cadista, 50 mg, bottle, 90 count, NDC 59746-0334-90
    • Losartan potassium oral tablet, Cadista, 50 mg, bottle, 1000 count, NDC 59746-0334-10
    • Losartan potassium oral tablet, Camber, 25 mg, bottle, 500 count, NDC 31722-0700-05 - discontinued
    • Losartan potassium oral tablet, Lupin, 100 mg, bottle, 90 count, NDC 68180-0378-09
    • Losartan potassium oral tablet, Lupin, 100 mg, bottle, 90 count, NDC 68180-0212-09
    • Losartan potassium oral tablet, Lupin, 100 mg, bottle, 1000 count, NDC 68180-0378-03
    • Losartan potassium oral tablet, Lupin, 100 mg, bottle, 1000 count, NDC 68180-0212-03
    • Losartan potassium oral tablet, Lupin, 25 mg, bottle, 90 count, NDC 68180-0376-09
    • Losartan potassium oral tablet, Lupin, 25 mg, bottle, 90 count, NDC 68180-0210-09
    • Losartan potassium oral tablet, Lupin, 25 mg, bottle, 1000 count, NDC 68180-0210-03
    • Losartan potassium oral tablet, Lupin, 25 mg, bottle, 1000 count, NDC 68180-0376-03
    • Losartan potassium oral tablet, Lupin, 50 mg, bottle, 90 count, NDC 68180-0377-09
    • Losartan potassium oral tablet, Lupin, 50 mg, bottle, 90 count, NDC 68180-0211-09
    • Losartan potassium oral tablet, Lupin, 50 mg, bottle, 1000 count, NDC 68180-0377-03
    • Losartan potassium oral tablet, Lupin, 50 mg, bottle, 1000 count, NDC 68180-0211-03
    • Losartan potassium oral tablet, Major, 100 mg, unit-dose blister pack, 100 count, NDC 00904-6389-61
    • Losartan potassium oral tablet, Rising Pharmaceuticals, 100 mg, bottle, 1000 count, NDC 57237-0206-99 - discontinued
    • Losartan potassium oral tablet, Rising Pharmaceuticals, 25 mg, bottle, 90 count, NDC 57237-0204-90 - discontinued
    • Losartan potassium oral tablet, Rising Pharmaceuticals, 25 mg, bottle, 1000 count, NDC 57237-0204-99 - discontinued
    • Losartan potassium oral tablet, Rising Pharmaceuticals, 50 mg, bottle, 90 count, NDC 57237-0205-90 - discontinued
    • Losartan potassium oral tablet, Rising Pharmaceuticals, 50 mg, bottle, 1000 count, NDC 57237-0205-99 - discontinued
    • Losartan potassium oral tablet, Sandoz, 100 mg, bottle, 30 count, NDC 00781-5702-31
    • Losartan potassium oral tablet, Sandoz, 100 mg, bottle, 90 count, NDC 00781-5702-92
    • Losartan potassium oral tablet, Sandoz, 100 mg, bottle, 1000 count, NDC 00781-5702-10
    • Losartan potassium oral tablet, Sandoz, 25 mg, bottle, 90 count, NDC 00781-5700-92
    • Losartan potassium oral tablet, Sandoz, 25 mg, bottle, 1000 count, NDC 00781-5700-10
    • Losartan potassium oral tablet, Sandoz, 50 mg, bottle, 30 count, NDC 00781-5701-31
    • Losartan potassium oral tablet, Sandoz, 50 mg, bottle, 90 count, NDC 00781-5701-92
    • Losartan potassium oral tablet, Sandoz, 50 mg, bottle, 1000 count, NDC 00781-5701-10
    • Losartan potassium oral tablet, Teva, 100 mg, bottle, 1000 count, NDC 00591-3747-10 - discontinued
    • Losartan potassium oral tablet, Teva, 25 mg, bottle, 1000 count, NDC 00591-3745-10 - discontinued
    • Losartan potassium oral tablet, Teva, 50 mg, bottle, 1000 count, NDC 00591-3746-10 - discontinued
    • Losartan potassium oral tablet, Zydus, 100 mg, bottle, 30 count, NDC 68382-0137-06
    • Losartan potassium oral tablet, Zydus, 100 mg, bottle, 90 count, NDC 68382-0137-16
    • Losartan potassium oral tablet, Zydus, 100 mg, bottle, 1000 count, NDC 68382-0137-10
    • Losartan potassium oral tablet, Zydus, 25 mg, bottle, 30 count, NDC 68382-0135-06
    • Losartan potassium oral tablet, Zydus, 25 mg, bottle, 90 count, NDC 68382-0135-16
    • Losartan potassium oral tablet, Zydus, 25 mg, bottle, 1000 count, NDC 68382-0135-10
    • Losartan potassium oral tablet, Zydus, 50 mg, bottle, 30 count, NDC 68382-0136-06
    • Losartan potassium oral tablet, Zydus, 50 mg, bottle, 90 count, NDC 68382-0136-16
    • Losartan potassium oral tablet, Zydus, 50 mg, bottle, 1000 count, NDC 68382-0136-10

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.
    • Camber, Heritage, Teva, and Torrent have been affected by the recall.
    • Alembic has losartan on back order due to manufacturing delays.
    • Aurobindo refuses to provide updated availability information.
    • Cadista has temporarily discontinued losartan tablets due to issues with obtaining active ingredient.
    • Camber has losartan tablets available.
    • Lupin, Sandoz, and Zydus did not provide a reason for the shortage.
    • Major has losartan tablets in unit-dose packages available.
    • Merck has Cozaar available.
    • Rising discontinued losartan in August 2019.
    • Teva discontinued losartan in 2018.
    • Torrent recalled several lots of losartan 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.

Available Products

    • Cozaar oral tablet, Merck, 100 mg, bottle, 30 count, NDC 00006-0960-31
    • Cozaar oral tablet, Merck, 100 mg, bottle, 90 count, NDC 00006-0960-54
    • Cozaar oral tablet, Merck, 25 mg, bottle, 90 count, NDC 00006-0951-54
    • Cozaar oral tablet, Merck, 50 mg, bottle, 30 count, NDC 00006-0952-31
    • Cozaar oral tablet, Merck, 50 mg, bottle, 90 count, NDC 00006-0952-54
    • Losartan potassium oral tablet, Alembic, 25 mg, bottle, 30 count, NDC 62332-0027-30
    • Losartan potassium oral tablet, Alembic, 25 mg, bottle, 90 count, NDC 62332-0027-90
    • Losartan potassium oral tablet, Camber, 100 mg, bottle, 30 count, NDC 31722-0702-30
    • Losartan potassium oral tablet, Camber, 100 mg, bottle, 90 count, NDC 31722-0702-90
    • Losartan potassium oral tablet, Camber, 100 mg, bottle, 1000 count, NDC 31722-0702-10
    • Losartan potassium oral tablet, Camber, 25 mg, bottle, 90 count, NDC 31722-0700-90
    • Losartan potassium oral tablet, Camber, 25 mg, bottle, 1000 count, NDC 31722-0700-10
    • Losartan potassium oral tablet, Camber, 50 mg, bottle, 30 count, NDC 31722-0701-30
    • Losartan potassium oral tablet, Camber, 50 mg, bottle, 90 count, NDC 31722-0701-90
    • Losartan potassium oral tablet, Camber, 50 mg, bottle, 1000 count, NDC 31722-0701-10
    • Losartan potassium oral tablet, Major, 25 mg, unit-dose blister pack, 100 count, NDC 00904-6391-61
    • Losartan potassium oral tablet, Major, 50 mg, unit-dose blister pack, 100 count, NDC 00904-6390-61

Estimated Resupply Dates

    • Alembic has losartan potassium 25 mg 1,000 count tablets and all 50 mg and 100 mg tablets on back order and the company estimates a release date of March 2020.
    • Avet has losartan potassium tablets on back order and the company cannot estimate a release date.
    • Cadista has temporarily discontinued losartan potassium tablets and the company cannot estimate when product will be available again.
    • Lupin has losartan potassium tablets on back order and the company cannot estimate a release date.
    • Major has losartan potassium 100 mg unit-dose tablets on back order and the company cannot estimate a release date.
    • Sandoz has losartan potassium tablets on back order and the company cannot estimate a release date.
    • Zydus has losartan potassium tablets on allocation.
    • Torrent has losartan potassium tablets on long term back order and the company estimates a relaunch in 2020.

Updated

Updated December 23, 2019 by Megan Dryer, PharmD. Created June 7, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2019, 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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