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Irbesartan Tablets Shortage

Last Updated: June 24, 2025
Status: Current

Products Affected - Description
    • Avapro oral tablet, Sanofi-Aventis, 300 mg, bottle, 30 count, NDC 00024-5852-30
    • Avapro oral tablet, Sanofi-Aventis, 75 mg, bottle, 90 count, NDC 00024-5850-90 - discontinued
    • Irbesartan oral tablet, Camber, 150 mg, bottle, 30 count, NDC 31722-0730-30
    • Irbesartan oral tablet, Camber, 150 mg, bottle, 90 count, NDC 31722-0730-90
    • Irbesartan oral tablet, Camber, 300 mg, bottle, 30 count, NDC 31722-0731-30
    • Irbesartan oral tablet, Camber, 300 mg, bottle, 90 count, NDC 31722-0162-05
    • Irbesartan oral tablet, Camber, 300 mg, bottle, 90 count, NDC 31722-0731-90
    • Irbesartan oral tablet, Camber, 75 mg, bottle, 30 count, NDC 31722-0729-30
    • Irbesartan oral tablet, Camber, 75 mg, bottle, 90 count, NDC 31722-0729-90
    • Irbesartan oral tablet, Lupin, 150 mg, bottle, 30 count, NDC 68180-0411-06 - discontinued
    • Irbesartan oral tablet, Lupin, 150 mg, bottle, 90 count, NDC 68180-0411-09 - discontinued
    • Irbesartan oral tablet, Lupin, 300 mg, bottle, 30 count, NDC 59746-0449-30 - discontinued
    • Irbesartan oral tablet, Lupin, 300 mg, bottle, 90 count, NDC 59746-0449-90 - discontinued
    • Irbesartan oral tablet, Lupin, 75 mg, bottle, 30 count, NDC 68180-0410-06 - discontinued
    • Irbesartan oral tablet, Lupin, 75 mg, bottle, 90 count, NDC 68180-0410-09 - discontinued
    • Irbesartan oral tablet, Winthrop, 150 mg, bottle, 90 count, NDC 00955-1041-90 - discontinued
    • Irbesartan oral tablet, Winthrop, 300 mg, bottle, 90 count, NDC 00955-1042-90 - discontinued
    • Irbesartan oral tablet, Winthrop, 75 mg, bottle, 90 count, NDC 00955-1040-90 - discontinued
Reason for the Shortage
    • Alembic has irbesartan available in 30 count and 90 count presentations.
    • 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 did not provide a reason for the shortage.
    • Chartwell has irbesartan tablets available.
    • Hikma and Westminster are not actively marketing irbesartan tablets.
    • MacLeod's has irbesartan tablets available.
    • Sanofi-Aventis did not provide a reason for the shortage. Sanofi-Aventis discontinued Avapro 75 mg tablets in early-2025.
    • Solco has irbesartan available to their direct customers.
    • Repackagers may have some presentations affected depending on the source supplier.
Available Products
    • Avapro oral tablet, Sanofi-Aventis, 150 mg, bottle, 30 count, NDC 00024-5851-30
    • Irbesartan oral tablet, Alembic, 150 mg, bottle, 30 count, NDC 62332-0042-30
    • Irbesartan oral tablet, Alembic, 150 mg, bottle, 90 count, NDC 62332-0042-90
    • Irbesartan oral tablet, Alembic, 300 mg, bottle, 30 count, NDC 62332-0043-30
    • Irbesartan oral tablet, Alembic, 300 mg, bottle, 90 count, NDC 62332-0043-90
    • Irbesartan oral tablet, Alembic, 75 mg, bottle, 30 count, NDC 62332-0041-30
    • Irbesartan oral tablet, Alembic, 75 mg, bottle, 90 count, NDC 62332-0041-90
    • Irbesartan oral tablet, Chartwell, 150 mg, bottle, 30 count, NDC 62135-0977-30
    • Irbesartan oral tablet, Chartwell, 150 mg, bottle, 90 count, NDC 62135-0977-90
    • Irbesartan oral tablet, Chartwell, 300 mg, bottle, 30 count, NDC 62135-0978-30
    • Irbesartan oral tablet, Chartwell, 300 mg, bottle, 90 count, NDC 62135-0978-90
    • Irbesartan oral tablet, Chartwell, 75 mg, bottle, 30 count, NDC 62135-0976-30
    • Irbesartan oral tablet, Chartwell, 75 mg, bottle, 90 count, NDC 62135-0976-90
    • Irbesartan oral tablet, Macleods, 150 mg, bottle, 30 count, NDC 33342-0048-07
    • Irbesartan oral tablet, Macleods, 150 mg, bottle, 90 count, NDC 33342-0048-10
    • Irbesartan oral tablet, Macleods, 300 mg, bottle, 30 count, NDC 33342-0049-07
    • Irbesartan oral tablet, Macleods, 300 mg, bottle, 90 count, NDC 33342-0049-10
    • Irbesartan oral tablet, Macleods, 75 mg, bottle, 30 count, NDC 33342-0047-07
    • Irbesartan oral tablet, Macleods, 75 mg, bottle, 90 count, NDC 33342-0047-10
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 30 count, NDC 43547-0375-03
    • Irbesartan oral tablet, Solco Healthcare US, 150 mg, bottle, 90 count, NDC 43547-0375-09
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 30 count, NDC 43547-0376-03
    • Irbesartan oral tablet, Solco Healthcare US, 300 mg, bottle, 90 count, NDC 43547-0376-09
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 30 count, NDC 43547-0374-03
    • Irbesartan oral tablet, Solco Healthcare US, 75 mg, bottle, 90 count, NDC 43547-0374-09

Estimated Resupply Dates

    • Camber has irbesartan tablets on allocation.
    • Sanofi-Aventis has Avapro 300 mg tablets available with short expiration dating (April 2026).

Updated

Updated June 24, 2025 by Leslie Jensen, PharmD, Drug Information Specialist. Created July 19, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2025, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

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