PhotoTorrent Pharmaceuticals Limited is expanding an earlier recall to include all lots of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets.

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:

NDCProduct DescriptionLot/BatchExpiration Date
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D025Nov-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D026Nov-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2E001Jan-2020
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2E002Jan-2020
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2E003Jan-2020
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2E004Jan-2020
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2E005Jan-2020
NDC 13668-328-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 TabletsBBX9D004Nov-2019
NDC 13668-328-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 TabletsBBX9E001Jan-2020
NDC 13668-326-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 TabletsBBY1E001Dec-2019
NDC 13668-326-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 TabletsBBY1E003Mar-2020
NDC 13668-327-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/12.5mg, 30 TabletsBBY2E001Mar-2020
NDC 13668-329-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 TabletsBBY4D004Nov-2019
NDC 13668-329-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 TabletsBBY4E001Jan-2020
NDC 13668-329-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 TabletsBBY4E001Jan-2020
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D003Mar-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D004Mar-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D005Mar-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D006Mar-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D007Mar-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D008Mar-2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D015Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D016Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D017Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D018Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D019Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D020Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D021Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D022Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D023Oct 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D024Nov 2019
NDC 13668-328-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 TabletsBBX9D001Feb 2019
NDC 13668-326-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 TabletsBBY1C002Sep 2018
NDC 13668-326-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 TabletsBBY1E002Mar-2020
13668-327-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/12.5mg, 30 TabletsBBY2D001Feb 2019
13668-327-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/12.5mg, 30 TabletsBBY2D002Nov 2019
NDC 13668-207-30Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 TabletsBV53D004Oct 2019
NDC 13668-206-30Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 TabletsBV65D002Oct 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D013Oct 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D010Oct 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84E001Dec 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D001Dec 2018
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D002Dec 2018
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D009Mar 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D010Apr 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D011Apr 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D012May 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D013May 2019
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2D014Aug 2019
NDC 13668-328-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 TabletsBBX9D002Mar 2019
NDC 13668-328-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/160mg/25mg, 30 TabletsBBX9D003Jul 2019
NDC 13668-326-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/12.5mg, 30 TabletsBBY1D001May 2019
NDC 13668-329-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 TabletsBBY4D001Apr 2019
NDC 13668-329-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 TabletsBBY4D002Apr 2019
NDC 13668-329-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 5mg/160mg/25mg, 30 TabletsBBY4D003Jun 2019
NDC 13668-068-90Valsartan Tablets, USP, 80 mg, 90 TabletsBV46C007Sept 2018
NDC 13668-068-90Valsartan Tablets, USP, 80 mg, 90 TabletsBV46C008Oct 2018
NDC 13668-068-90Valsartan Tablets, USP, 80 mg, 90 TabletsBV46C009Oct 2018
NDC 13668-068-90Valsartan Tablets, USP, 80 mg, 90 TabletsBV46C010Oct 2018
NDC 13668-068-90Valsartan Tablets, USP, 80 mg, 90 TabletsBV46C011Nov 2018
NDC 13668-068-90Valsartan Tablets, USP, 80 mg, 90 TabletsBV46C012Nov 2018
NDC 13668-069-90Valsartan Tablets, USP,160 mg, 90 TabletsBV47C005Sep 2018
NDC 13668-069-90Valsartan Tablets, USP, 160 mg, 90 TabletsBV47C006Sept 2018
NDC 13668-069-90Valsartan Tablets, USP, 160 mg, 90 TabletsBV47D001Dec 2018
NDC 13668-070-90Valsartan Tablets, USP, 320 mg, 90 TabletsBV48D001Dec 2018
NDC 13668-070-90Valsartan Tablets, USP, 320 mg, 90 TabletsBV48D002Dec 2018
NDC 13668-207-30Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 TabletsBV53C006Nov 2018
NDC 13668-207-30Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 TabletsBV53D001Feb 2019
NDC 13668-207-30Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 TabletsBV53D002Feb 2019
NDC 13668-207-30Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 TabletsBV53D003Sep 2019
NDC 13668-206-30Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 TabletsBV65C002Sep 2018
NDC 13668-206-30Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 TabletsBV65C003Oct 2018
NDC 13668-206-30Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 TabletsBV65C004Nov 2018
NDC 13668-206-30Amlodipine and Valsartan Tablets 10 mg/160 mg, USP, 30 TabletsBV65D001Aug 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77C011Oct 2018
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D001Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D002Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D003Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D004Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D005Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D006Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D007Feb 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D008May 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D009Aug 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D010Sep 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D011Sep 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77D012Sep 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84C011Oct 2018
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D001Jan 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D002Jan 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D005Feb 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D006Feb 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D007Feb 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D008May 2019
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84D009May 2019
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77C009Aug 2018
NDC 13668-204-30Amlodipine and Valsartan Tablets 10 mg/320 mg, USP, 30 TabletsBV77C010Aug 2018
NDC 13668-207-30Amlodipine and Valsartan Tablets 5 mg/160 mg, USP, 30 TabletsBV53C004Aug 2018
NDC 13668-207-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV53C005Aug 2018
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84C006Aug 2018
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84C007Aug 2018
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84C008Aug 2018
NDC 13668-205-30Amlodipine and Valsartan Tablets 5 mg/320 mg, USP, 30 TabletsBV84C009Aug 2018
NDC 13668-325-30Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP 10mg/320mg/25mg, 30 TabletsBBX2C007Aug 2018
NDC 13668-069-90Valsartan Tablets USP, 160 mg, 90 TabletsBV47C003Aug 2018
NDC 13668-069-90Valsartan Tablets USP, 160 mg, 90 TabletsBV47C004Aug 2018
NDC 13668-068-90Valsartan Tablets USP, 80 mg, 90 TabletsBV46C003Aug 2018
NDC 13668-068-90Valsartan Tablets USP, 80 mg, 90 TabletsBV46C006Aug 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).


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