PhotoTorrent Pharmaceuticals Limited is expanding its earlier recall of Losartan Potassium tablets and Losartan Potassium/hydrochlorothiazide tablets.

The products, used to treat high blood pressure, hypertensive patients with Left Ventricular Hypertrophy and nephropathy in Type 2 diabetic patients, contain trace amounts of an unexpected impurity, N-Methylnitrosobutyric acid that are above the acceptable daily intake levels released by the FDA.

There are no reports to date of adverse events related to this recall.

The expanded recall includes the following 36 lots of Losartan potassium tablets and 68 lots of Losartan Potassium/Hydrochlorothiazide tablets:

NDCFinished Product Strength and Package CountBatch NumberExpiration Date
13668-113-90Losartan Potassium Tablets, USP 25mg, 90 countBDK1C0037/31/2019
13668-113-10Losartan Potassium Tablets, USP 25mg, 1000 countBDK1C0027/31/2019
13668-113-10Losartan Potassium Tablets, USP 25mg, 1000 count4DU1D00412/31/2019
13668-113-10Losartan Potassium Tablets, USP 25mg, 1000 count4DU1D00512/31/2019
13668-113-10Losartan Potassium Tablets, USP 25mg, 1000 count4DU1D00612/31/2019
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2D00512/31/2019
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2D00612/31/2019
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2D0263/31/2020
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2D0273/31/2020
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2D0293/31/2020
13668-409-90Losartan Potassium Tablets, USP 50mg,90 count4DU2E00712/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0408/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0418/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0428/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0172/29/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0253/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0283/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0458/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0468/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0478/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0488/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0422/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0442/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 countBDK2E00112/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 countBDK2E0128/31/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 countBDK2E0138/31/2021
13668-115-90Losartan Potassium Tablets, USP 100mg, 90 count4DU3E0161/31/2021
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3E0171/31/2021
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3E0192/28/2021
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3C0127/31/2019
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3C0158/31/2019
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3C0168/31/2019
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3C0178/31/2019
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3C0319/30/2019
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3D0071/31/2020
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3D0081/31/2020
13668-116-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 countBP02D00512/31/2019
13668-116-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 countBP02C05110/31/2019
13668-116-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 countBEF7D04711/30/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBP02D00612/31/2019
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBP02D00712/31/2019
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBP02D0121/31/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0033/31/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBP02C05010/31/2019
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0268/31/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0278/31/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0288/31/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D04511/30/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D04611/30/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7E0051/31/2021
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0053/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0298/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0308/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D04811/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7E00112/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7E00212/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7E00312/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7E00412/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBP02C05110/31/2019
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBP02C05210/31/2019
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D06011/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D06111/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D06211/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D06311/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBX35D0241/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D06411/30/2020
13668-117-10Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 countBEF8D05911/30/2020
13668-117-10Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 countBEF8E0041/31/2021
13668-117-10Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 countBEF8E0051/31/2021
13668-118-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 30 countBEF6D0548/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D10011/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D10111/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D10211/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E00112/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E00212/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E00312/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E00412/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E00812/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E00912/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E01012/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E01112/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E01212/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBP04D01212/31/2019
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBP04D01312/31/2019
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBP04C09210/31/2019
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0123/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0133/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0609/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0619/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0639/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D07610/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D07710/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D07810/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D07910/31/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBP04C09410/31/2019
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBEF6D09611/30/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBEF6D09711/30/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBEF6D09811/30/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBEF6D09911/30/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBEF6E00512/31/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBEF6E00612/31/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBP04D0162/29/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBP04D0172/29/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBP04D0182/29/2020

What to do

Patients who are taking the recalled products should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.

Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

Torrent is notifying its customers by phone and in writing, and arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions regarding this recall or to report an adverse event may contact Torrent Pharmaceuticals Limited at (800) 912-9561 from 8:00 am – 5:00 pm (ET) with voicemail available 24/7, or by email at Medinfo.Torrent@apcerls.com

Consumers with general questions regarding the return of the recalled product may contact Qualanex at (888) 280-2040 from 8 am - 9:00 pm ET).


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