Trace amounts of N-Nitrosodimethylamine impurity were found in an active pharmaceutical ingredient (API).
NDMA is classified as a probable human carcinogen (a substance that could cause cancer).
The company has not received any reports of adverse events to date related to this recall.
Valsartan is used to control high blood pressure and for the treatment of heart failure. In combination with amlodipine or amlodipine plus hydrochlorothiazide, it is used to control high blood pressure.
The following products, packaged in bottles and distributed nationwide, are being recalled:
| NDC | Product Descrip. | Lot/Batch | Expiration Date |
|---|---|---|---|
NDC 13668 -325 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg 30 Tablets | BBX2D025 | Nov-2019 |
NDC 13668 -325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg 30 Tablets | BBX2D026 | Nov-2019 |
NDC 13668- 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2E001 | Jan-2020 |
NDC 13668 -325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg, 30 Tablets | BBX2E002 | Jan-2020 |
NDC 13668 -325 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2E003 | Jan-2020 |
NDC 13668 -325 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2E004 | Jan-2020 |
NDC 13668 -325 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2E005 | Jan-2020 |
NDC 13668 -328- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/160mg/25mg 30 Tablets | BBX9D004 | Nov-2019 |
NDC 13668- 328- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/160mg/25mg 30 Tablets | BBX9E001 | Jan-2020 |
NDC 13668 -326- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 5mg/160mg/12.5mg 30 Tablets | BBY1E001 | Dec-2019 |
NDC 13668 -326- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 5mg/160mg/12.5mg 30 Tablets | BBY1E003 | Mar-2020 |
NDC 13668 -327 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/160mg/12.5mg 30 Tablets | BBY2E001 | Mar-2020 |
NDC 13668 -329 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 5mg/160mg/25mg 30 Tablets | BBY4D004 | Nov-2019 |
NDC 13668- 329- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 5mg/160mg/25mg 30 Tablets | BBY4E001 | Jan-2020 |
NDC 13668- 329- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 5mg/160mg/25mg 30 Tablets | BBY4E001 | Jan-2020 |
NDC 13668- 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D003 | Mar-2019 |
NDC 13668- 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D004 | Mar-2019 |
NDC 13668 -325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D005 | Mar-2019 |
NDC 13668- 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D006 | Mar-2019 |
NDC 13668- 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D007 | Mar-2019 |
NDC 13668- 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D008 | Mar-2019 |
NDC 13668- 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D015 | Oct 2019 |
NDC 13668- 325 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D016 | Oct 2019 |
NDC 13668- 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D017 | Oct 2019 |
NDC 13668 -325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D018 | Oct 2019 |
NDC 13668 -325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D019 | Oct 2019 |
NDC 13668- 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D020 | Oct 2019 |
NDC 13668- 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D021 | Oct 2019 |
NDC 13668- 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D022 | Oct 2019 |
NDC 13668 -325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D023 | Oct 2019 |
NDC 13668 -325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D024 | Nov 2019 |
NDC 13668- 328- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/160mg/25mg 30 Tablets | BBX9D001 | Feb 2019 |
NDC 13668- 326- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 5mg/160mg/12.5mg 30 Tablets | BBY1C002 | Sep 2018 |
NDC 13668 -326- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 5mg/160mg/12.5mg 30 Tablets | BBY1E002 | Mar-2020 |
13668 -327- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/160mg/12.5mg , 30 Tablets | BBY2D001 | Feb 2019 |
13668- 327-3 0 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/160mg/12.5mg 30 Tablets | BBY2D002 | Nov 2019 |
NDC 13668- 207- 30 | Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 3 0 Tablets | BV53D004 | Oct 2019 |
NDC 13668 -206- 30 | Amlodipine and Valsartan Tablets 10 mg/160 mg, USP 30 Tablets | BV65D002 | Oct 2019 |
NDC 13668 -204 -30 | Amlodipine and Valsartan Tablets 10 mg/320 mg, USP 30 Tablets | BV77D013 | Oct 2019 |
NDC 13668 -205 -30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP 30 Tablets | BV84D010 | Oct 2019 |
NDC 13668- 205- 30 | Amlodipine and Valsartan Tablets 5 mg/320 mg, USP 30 Tablets | BV84E001 | Dec 2019 |
NDC 13668 -325 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D001 | Dec 2018 |
NDC 13668 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D002 | Dec 2018 |
NDC 13668 -325 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D009 | Mar 2019 |
NDC 13668 -325 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D010 | Apr 2019 |
NDC 13668 -325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D011 | Apr 2019 |
NDC 13668- 325- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D012 | May 2019 |
NDC 13668 -325 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D013 | May 2019 |
NDC 13668 -325 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/320mg/25mg 30 Tablets | BBX2D014 | Aug 2019 |
NDC 13668 -328- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/160mg/25mg 30 Tablets | BBX9D002 | Mar 2019 |
NDC 13668 -328- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 10mg/160mg/25mg 30 Tablets | BBX9D003 | Jul 2019 |
NDC 13668 -326- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 5mg/160mg/12.5mg 30 Tablets | BBY1D001 | May 2019 |
NDC 13668 -329- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 5mg/160mg/25mg 30 Tablets | BBY4D001 | Apr 2019 |
NDC 13668 -329- 30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 5mg/160mg/25mg 30 Tablets | BBY4D002 | Apr 2019 |
NDC 13668 -329 -30 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP 5mg/160mg/25mg 30 Tablets | BBY4D003 | Jun 2019 |
NDC 13668- 068- 90 | Valsartan Tablets, USP 80 mg, 90 Tablets | BV46C007 | Sept 2018 |
NDC 13668- 068- 90 | Valsartan Tablets, USP 80 mg, 90 Tablets | BV46C008 | Oct 2018 |
NDC 1366 -068 -90 | Valsartan Tablets, USP 80 mg, 90 Tablets | BV46C009 | Oct 2018 |
NDC 13668 -068 -90 | Valsartan Tablets, USP 80 mg, 90 Tablets | BV46C010 | Oct 2018 |
NDC 13668 -068 -90 | Valsartan Tablets, USP 80 mg, 90 Tablets | BV46C011 | Nov 2018 |
NDC 13668 -068- 90 | Valsartan Tablets, USP 80 mg, 90 Tablets | BV46C012 | Nov 2018 |
NDC 13668 -069 -90 | Valsartan Tablets, USP 160 mg, 90 Tablets | BV47C005 | Sep 2018 |
NDC 13668 -069 -90 | Valsartan Tablets, USP 160 mg, 90 Tablets | BV47C006 | Sept 2018 |
NDC 13668 -069 -90 | Valsartan Tablets, USP 160 mg, 90 Tablets | BV47D001 | Dec 2018 |
NDC 13668 -070 -90 | Valsartan Tablets, USP , 320 mg, 90 Tablets | BV48D001 | Dec 2018 |
NDC 13668 -070 -90 | Valsartan Tablets, USP 320 mg, 90 Tablets | BV48D002 | Dec 2018 |
NDC 13668 -207 -30 | Amlodipine and Valsartan Tablets 5 mg/160 mg USP, 30 Tablets | BV53C006 | Nov 2018 |
NDC 13668 -207 -30 | Amlodipine and Valsaran Tablets 5 mg/160 mg USP, 30 Tablets | BV53D001 | Feb 2019 |
NDC 13668 -207- 30 | Amlodipine and Valsartan Tablets 5 mg/160 mg USP, 30 Tablets | BV53D002 | Feb 2019 |
NDC 13668- 207- 30 | Amlodipine and Valsartan Tablets 5 mg/160 mg USP, 30 Tablets | BV53D003 | Sep 2019 |
NDC 13668 -206 -30 | Amlodipine and Valsartan Tablets 10 mg/160 mg USP, 30 Tablets | BV65C002 | Sep 2018 |
NDC 13668 -206- 30 | Amlodipine and Valsartan Tablets 10 mg/160 mg USP, 30 Tablets | BV65C003 | Oct 2018 |
NDC 13668 -206- 30 | Amlodipine and Valsartan Tablets 10 mg/160 mg USP, 30 Tablets | BV65C004 | Nov 2018 |
NDC 13668- 206- 30 | Amlodipine and Valsartan Tablets 10 mg/160 mg USP, 30 Tablets | BV65D001 | Aug 2019 |
NDC 13668- 204- 30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77C011 | Oct 2018 |
NDC 13668- 204 -30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77D001 | Feb 2019 |
NDC 13668 -204- 30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77D002 | Feb 2019 |
NDC 13668- 204 -30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77D003 | Feb 2019 |
NDC 13668- 204- 30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77D004 | Feb 2019 |
NDC 13668- 204- 30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77D005 | Feb 2019 |
NDC 13668 -204- 30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77D006 | Feb 2019 |
NDC 13668- 204- 30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77D007 | Feb 2019 |
NDC 13668- 204- 30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77D008 | May 2019 |
NDC 13668 -204- 30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77D009 | Aug 2019 |
NDC 13668- 204- 30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77D010 | Sep 2019 |
NDC 13668- 204- 30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77D011 | Sep 2019 |
NDC 13668- 204- 30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77D012 | Sep 2019 |
NDC 13668- 205 -30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV84C011 | Oct 2018 |
NDC 13668 -205 -30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV84D001 | Jan 2019 |
NDC 13668 -205 -30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV84D002 | Jan 2019 |
NDC 13668- 205- 30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV84D005 | Feb 2019 |
NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV84D006 | Feb 2019 |
NDC 13668- 205 -30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV84D007 | Feb 2019 |
NDC 13668 -205- 30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV84D008 | May 2019 |
NDC 13668 -205 -30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV84D009 | May 2019 |
NDC 13668- 204 -30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77C009 | Aug 2018 |
NDC 13668 -204 -30 | Amlodipine and Valsartan Tablets 10 mg/320 mg USP, 30 Tablets | BV77C010 | Aug 2018 |
NDC 13668 -207 -30 | Amlodipine and Valsartan Tablets 5 mg/160 mg USP, 30 Tablets | BV53C004 | Aug 2018 |
NDC 13668 -207 -30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV53C005 | Aug 2018 |
NDC 13668 -205 -30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV84C006 | Aug 2018 |
NDC 13668 -205 -30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV84C007 | Aug 2018 |
NDC 13668 -205 -30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV84C008 | Aug 2018 |
NDC 13668-205-30 | Amlodipine and Valsartan Tablets 5 mg/320 mg USP, 30 Tablets | BV84C009 | Aug 2018 |
NDC 13668- 325 -30 | Amlodipine Valsartan and Hydrochlorothiazide Tablets USP 10mg/ 320mg/ 25mg 30 Tablets | BBX2C007 | Aug 2018 |
NDC 13668 -069 -90 | Valsartan Tablets USP 160 mg 90 Tablets | BV47C003 | Aug 2018 |
NDC 13668 -069- 90 | Valsartan Tablets USP 160 mg 90 Tablets | BV47C004 | Aug 2018 |
NDC 13668 -068- 90 | Valsartan Tablets USP 80 mg 90 Tablets | BV46C003 | Aug 2018 |
NDC 13668 -068- 90 | Valsartan Tablets USP , 80 mg 90 Tablets | BV46C006 | Aug 2018 |
What to do
The company is arranging for return of all recalled products to Qualanex LLC, with instructions for returning recalled products are given in the recall letter.
Consumers with questions regarding this recall or reporting an adverse event may contact Torrent at (800) 912-9561 from 8:00 am – 5:00 pm, or by email at Medinfo.Torrent@apcerls.com.
For general questions regarding the return of the recalled products, contact Qualanex at (800) 505-9291 from 8 am -5:30 pm (ET).