PhotoTorrent 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 CountBatch NumberExpiration Date
13668-113-90Losartan Potassium Tablets, USP 25mg, 90 count4DU1E0051/31/2021
13668-113-90Losartan Potassium Tablets, USP 25mg, 90 count4DU1E0061/31/2021
13668-113-90Losartan Potassium Tablets, USP 25mg, 90 count4DU1E0081/31/2021
13668-113-10Losartan Potassium Tablets, USP 25mg, 1000 count4DU1E0071/31/2021
13668-409-30Losartan Potassium Tablets, USP 50mg, 30 count4DU2D07710/31/2020
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2D08710/31/2020
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0231/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0241/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0261/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0271/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0281/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0291/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0201/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4O50E0078/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4O50E0088/31/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0679/30/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0699/30/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0639/30/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0649/30/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0659/30/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0669/30/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08410/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08510/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08310/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08210/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07210/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07710/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07810/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07910/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08110/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08010/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07010/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07310/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07410/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07510/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08610/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08810/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08910/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0191/31/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0211/31/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0221/31/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0251/31/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0322/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0332/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0342/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0352/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0362/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0372/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0382/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0392/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0412/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E1036/30/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E1016/30/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E1026/30/2021
13668-115-90Losartan Potassium Tablets, USP 100mg, 90 count4DU3E0141/31/2021
13668-115-90Losartan Potassium Tablets, USP 100mg, 90 count4DU3E0151/31/2021
13668-115-90Losartan Potassium Tablets, USP 100mg, 90 count4DU3E0657/31/2021
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3D01811/30/2020
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3E0626/30/2021
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3E0636/30/2021
13668-116-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 countBEF7D0176/30/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0104/30/2020
13668-116-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0114/30/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0186/30/2020
13668-116-90Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0094/30/2020
13668-116-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count4P02E0021/31/2021
13668-116-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count4P02E0031/31/2021
13668-116-90Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count4P02E0041/31/2021
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0084/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0228/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0124/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0134/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D04911/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count4P02E0051/31/2021
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count4P02E0061/31/2021
13668-117-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 30 countBEF8D05811/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0234/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0244/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0254/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0093/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0103/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0113/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0123/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0133/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D05410/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D05510/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D05610/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D05711/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0073/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0083/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0204/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0214/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0224/30/2020
13668-118-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 30 countBEF6D0384/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0304/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0314/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0477/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90countBEF6D0487/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0497/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0507/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0517/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08210/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08310/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08410/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08510/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08610/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08710/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count4P04E0031/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count4P04E0041/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count4P04E0051/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count4P04E0061/31/2021
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count4P04E0071/31/2021
13668-118-10Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count4P04E0081/31/2021
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count4P04E0091/31/2021

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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