Skip to Content

Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP

Audience: Consumer, Health Professional, Pharmacy

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan potassium and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium/ Hydrochlorothiazide Tablets, USP 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.

The products subject to recall are listed below. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan Potassium Tablet and Losartan Potassium/ Hydrochlorothiazide Tablet Lots

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

Losartan potassium tablets, USP and Losartan potassium/ hydrochlorothiazide tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers. Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is 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 can contact Torrent Pharmaceuticals Limited at:

  • 1-800-912-9561 (live calls received 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).

  • Medinfo.Torrent@apcerls.com

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Any general questions regarding the return of this product should be directed to Qualanex at 1- 888-280-2040 (live calls received 8 am - 9:00 pm Eastern Time).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm

Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Hide