Skip to main content

Valsartan and Hydrochlorothiazide Tablets Shortage

Last Updated: July 29, 2022
Status: Current

Products Affected - Description
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 160 mg/25 mg, bottle, 500 count, NDC 00378-6323-05 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 320 mg/12.5 mg, bottle, 500 count, NDC 00378-6324-05 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 320 mg/25 mg, bottle, 500 count, NDC 00378-6325-05 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 80 mg/12.5 mg, bottle, 500 count, NDC 00378-6321-05 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Solco Healthcare US, 160 mg/12.5 mg, bottle, 90 count, NDC 43547-0312-09 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Solco Healthcare US, 160 mg/25 mg, bottle, 90 count, NDC 43547-0313-09 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Solco Healthcare US, 320 mg/12.5 mg, bottle, 90 count, NDC 43547-0314-09 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Solco Healthcare US, 320 mg/25 mg, bottle, 90 count, NDC 43547-0315-09 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Solco Healthcare US, 80 mg/12.5 mg, bottle, 90 count, NDC 43547-0311-09 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Teva, 160 mg/12.5 mg, bottle, 90 count, NDC 00591-2316-19 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Teva, 160 mg/25 mg, bottle, 90 count, NDC 00591-2317-19 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Teva, 320 mg/12.5 mg, bottle, 90 count, NDC 00591-2318-19 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Teva, 320 mg/25 mg, bottle, 90 count, NDC 00591-2319-19 - discontinued
    • Valsartan and Hydrochlorothiazide oral tablet, Teva, 80 mg/12.5 mg, bottle, 90 count, NDC 00591-2315-19 - discontinued
Reason for the Shortage
    • Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probably human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.
    • Solco and Teva valsartan/hydrochlorothiazide tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.
    • Alembic has valsartan/hydrochlorothiazide tablets available.
    • Aurobindo refused to provide updated availability information.
    • Lupin has not provided recent availability updates.
    • Macleods has valsartan/hydrochlorothiazide tablets available.
    • Mylan discontinued valsartan/hydrochlorothiazide tablet presentations in 500 count bottles in June 2021.
    • Repackagers may have some presentations affected depending on the source supplier.
Available Products
    • Diovan HCT oral tablet, Novartis, 160 mg/12.5 mg, bottle, 90 count, NDC 00078-0315-34
    • Diovan HCT oral tablet, Novartis, 160 mg/25 mg, bottle, 90 count, NDC 00078-0383-34
    • Diovan HCT oral tablet, Novartis, 320 mg/12.5 mg, bottle, 90 count, NDC 00078-0471-34
    • Diovan HCT oral tablet, Novartis, 80 mg/12.5 mg, bottle, 90 count, NDC 00078-0314-34
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 160 mg/12.5 mg, bottle, 90 count, NDC 62332-0080-90
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 160 mg/12.5 mg, bottle, 500 count, NDC 62332-0080-71
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 160 mg/25 mg, bottle, 90 count, NDC 62332-0081-90
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 160 mg/25 mg, bottle, 500 count, NDC 62332-0081-71
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 320 mg/12.5 mg, bottle, 90 count, NDC 62332-0082-90
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 320 mg/12.5 mg, bottle, 500 count, NDC 62332-0082-71
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 320 mg/25 mg, bottle, 90 count, NDC 62332-0083-90
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 320 mg/25 mg, bottle, 500 count, NDC 62332-0083-71
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 80 mg/12.5 mg, bottle, 90 count, NDC 62332-0079-90
    • Valsartan and Hydrochlorothiazide oral tablet, Alembic, 80 mg/12.5 mg, bottle, 500 count, NDC 62332-0079-71
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 160 mg/12.5 mg, bottle, 90 count, NDC 68180-0104-09
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 160 mg/12.5 mg, bottle, 500 count, NDC 68180-0104-02
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 160 mg/25 mg, bottle, 90 count, NDC 68180-0105-09
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 320 mg/12.5 mg, bottle, 90 count, NDC 68180-0101-09
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 320 mg/12.5 mg, bottle, 500 count, NDC 68180-0101-02
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 320 mg/25 mg, bottle, 90 count, NDC 68180-0102-09
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 320 mg/25 mg, bottle, 500 count, NDC 68180-0102-02
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 80 mg/12.5 mg, bottle, 90 count, NDC 68180-0103-09
    • Valsartan and Hydrochlorothiazide oral tablet, Lupin, 80 mg/12.5 mg, bottle, 500 count, NDC 68180-0103-02
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 160 mg/12.5 mg, bottle, 90 count, NDC 33342-0075-10
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 160 mg/12.5 mg, bottle, 500 count, NDC 33342-0075-15
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 160 mg/25 mg, bottle, 90 count, NDC 33342-0076-10
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 160 mg/25 mg, bottle, 500 count, NDC 33342-0076-15
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 320 mg/12.5 mg, bottle, 90 count, NDC 33342-0077-10
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 320 mg/12.5 mg, bottle, 500 count, NDC 33342-0077-15
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 320 mg/25 mg, bottle, 90 count, NDC 33342-0078-10
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 320 mg/25 mg, bottle, 500 count, NDC 33342-0078-15
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 80 mg/12.5 mg, bottle, 80 count, NDC 33342-0074-44
    • Valsartan and Hydrochlorothiazide oral tablet, Macleods, 80 mg/12.5 mg, bottle, 90 count, NDC 33342-0074-10
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 160 mg/12.5 mg, bottle, 90 count, NDC 00378-6322-77
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 160 mg/25 mg, bottle, 90 count, NDC 00378-6323-77
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 320 mg/12.5 mg, bottle, 90 count, NDC 00378-6324-77
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 320 mg/25 mg, bottle, 90 count, NDC 00378-6325-77
    • Valsartan and Hydrochlorothiazide oral tablet, Mylan, 80 mg/12.5 mg, bottle, 90 count, NDC 00378-6321-77

Updated

Updated July 29, 2022 by Anthony Trovato, PharmD, BCPS. Created July 17, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2022, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer