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Torrent Pharmaceuticals recalls Losartan Potassium and Losartan Potassium /Hydrochlorothiazide tablets

The products contain trace amounts of an unexpected impurity

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Photo source: FDA
Torrent Pharmaceuticals Limited is recalling 60 lots of Losartan potassium tablets and 54 lots of Losartan potassium/ hydrochlorothiazide tablets

The products, used to treat high blood pressure, contain trace amounts of an unexpected impurity, N-Methylnitrosobutyric acid (NMBA), 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 following products are being recalled:

NDCFinished Product Strength
and Package Count
Batch NumberExpiration Date
13668-113-90Losartan Potassium Tablets,
USP 25mg,
90 count
4DU1E0051/31/2021
13668-113-90Losartan Potassium Tablets,
USP 25mg,
90 count
4DU1E0061/31/2021
13668-113-90Losartan Potassium Tablets,
USP 25mg,
90 count
4DU1E0081/31/2021
13668-113-10Losartan Potassium Tablets,
USP 25mg,
1000 count
4DU1E0071/31/2021
13668-409-30Losartan Potassium Tablets,
USP 50mg,
30 count
4DU2D07710/31/2020
13668-409-90Losartan Potassium Tablets,
USP 50mg,
90 count
4DU2D08710/31/2020
13668-409-90Losartan Potassium Tablets,
USP 50mg,
90 count
4DU2E0231/31/2021
13668-409-90Losartan Potassium Tablets,
USP 50mg,
90 count
4DU2E0241/31/2021
13668-409-90Losartan Potassium Tablets,
USP 50mg,
90 count
4DU2E0261/31/2021
13668-409-90Losartan Potassium Tablets,
USP 50mg,
90 count
4DU2E0271/31/2021
13668-409-90Losartan Potassium Tablets,
USP 50mg,
90 count
4DU2E0281/31/2021
13668-409-90Losartan Potassium Tablets,
USP 50mg,
90 count
4DU2E0291/31/2021
13668-409-90Losartan Potassium Tablets,
USP 50mg,
90 count
4DU2E0201/31/2021
13668-409-90Losartan Potassium Tablets,
USP 50mg,
90 count
4O50E0078/31/2021
13668-409-90Losartan Potassium Tablets,
USP 50mg,
90 count
4O50E0088/31/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D0679/30/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D0699/30/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D0639/30/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D0649/30/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D0659/30/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D0669/30/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D08410/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D08510/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D08310/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D08210/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D07210/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D07710/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D07810/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D07910/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D08110/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D08010/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D07010/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D07310/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D07410/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D07510/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D08610/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D08810/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2D08910/31/2020
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0191/31/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0211/31/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0221/31/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0251/31/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0322/28/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0332/28/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0342/28/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0352/28/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0362/28/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0372/28/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0382/28/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0392/28/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E0412/28/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E1036/30/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E1016/30/2021
13668-409-10Losartan Potassium Tablets,
USP 50mg,
1000 count
4DU2E1026/30/2021
13668-115-90Losartan Potassium Tablets,
USP 100mg,
90 count
4DU3E0141/31/2021
13668-115-90Losartan Potassium Tablets,
USP 100mg,
90 count
4DU3E0151/31/2021
13668-115-90Losartan Potassium Tablets,
USP 100mg,
90 count
4DU3E0657/31/2021
13668-115-10Losartan Potassium Tablets,
USP 100mg,
1000 count
4DU3D01811/30/2020
13668-115-10Losartan Potassium Tablets,
USP 100mg,
1000 count
4DU3E0626/30/2021
13668-115-10Losartan Potassium Tablets,
USP 100mg,
1000 count
4DU3E0636/30/2021
13668-116-30Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
30 count
BEF7D0176/30/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
90 count
BEF7D0104/30/2020
13668-116-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
90 count
BEF7D0114/30/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
90 count
BEF7D0186/30/2020
13668-116-90Losartan Potassium / Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
90 count
BEF7D0094/30/2020
13668-116-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
90 count
4P02E0021/31/2021
13668-116-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
90 count
4P02E0031/31/2021
13668-116-90Losartan Potassium / Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
90 count
4P02E0041/31/2021
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
1000 count
BEF7D0084/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
1000 count
BEF7D0228/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
1000 count
BEF7D0124/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
1000 count
BEF7D0134/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
1000 count
BEF7D04911/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
1000 count
4P02E0051/31/2021
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 50mg/12.5mg,
1000 count
4P02E0061/31/2021
13668-117-30Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
30 count
BEF8D05811/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0234/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0244/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0254/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0093/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0103/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0113/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0123/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0133/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D05410/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D05510/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D05610/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D05711/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0073/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0083/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0204/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0214/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/12.5mg,
90 count
BEF8D0224/30/2020
13668-118-30Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
30 count
BEF6D0384/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
BEF6D0304/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
BEF6D0314/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
BEF6D0477/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90count
BEF6D0487/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
BEF6D0497/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
BEF6D0507/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
BEF6D0517/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
BEF6D08210/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
BEF6D08310/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
BEF6D08410/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
BEF6D08510/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
BEF6D08610/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
BEF6D08710/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
4P04E0031/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
4P04E0041/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
4P04E0051/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
90 count
4P04E0061/31/2021
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
1000 count
4P04E0071/31/2021
13668-118-10Losartan Potassium/Hydrochlorothiazide Tablets,
USP 100mg/25mg,
1000 count
4P04E0081/31/2021
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets,
USP 100mg/25mg,
1000 count
4P04E0091/31/2021

The recalled products were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers

What to do

Patients who are taking the medications should continue to do so, as the risk of harm to their 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 arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in a letter being sent to all customers.

Consumers with medical questions regarding this recall may contact Torrent Pharmaceuticals at (800) 912-9561 from 8:00 am – 5:00 pm (ET) or by email at Medinfo.Torrent@apcerls.com

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