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:
| NDC | Finished Product Strength and Package Count | Batch Number | Expiration Date |
|---|---|---|---|
| 13668-113-90 | Losartan Potassium Tablets, USP 25mg, 90 count | BDK1C003 | 7/31/2019 |
| 13668-113-10 | Losartan Potassium Tablets, USP 25mg, 1000 count | BDK1C002 | 7/31/2019 |
| 13668-113-10 | Losartan Potassium Tablets, USP 25mg, 1000 count | 4DU1D004 | 12/31/2019 |
| 13668-113-10 | Losartan Potassium Tablets, USP 25mg, 1000 count | 4DU1D005 | 12/31/2019 |
| 13668-113-10 | Losartan Potassium Tablets, USP 25mg, 1000 count | 4DU1D006 | 12/31/2019 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2D005 | 12/31/2019 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2D006 | 12/31/2019 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2D026 | 3/31/2020 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2D027 | 3/31/2020 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2D029 | 3/31/2020 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg,90 count | 4DU2E007 | 12/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D040 | 8/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D041 | 8/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D042 | 8/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D017 | 2/29/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D025 | 3/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D028 | 3/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D045 | 8/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D046 | 8/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D047 | 8/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D048 | 8/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E042 | 2/28/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E044 | 2/28/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | BDK2E001 | 12/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | BDK2E012 | 8/31/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | BDK2E013 | 8/31/2021 |
| 13668-115-90 | Losartan Potassium Tablets, USP 100mg, 90 count | 4DU3E016 | 1/31/2021 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3E017 | 1/31/2021 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3E019 | 2/28/2021 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3C012 | 7/31/2019 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3C015 | 8/31/2019 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3C016 | 8/31/2019 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3C017 | 8/31/2019 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3C031 | 9/30/2019 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3D007 | 1/31/2020 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3D008 | 1/31/2020 |
| 13668-116-30 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count | BP02D005 | 12/31/2019 |
| 13668-116-30 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count | BP02C051 | 10/31/2019 |
| 13668-116-30 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count | BEF7D047 | 11/30/2020 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BP02D006 | 12/31/2019 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BP02D007 | 12/31/2019 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BP02D012 | 1/31/2020 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BEF7D003 | 3/31/2020 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BP02C050 | 10/31/2019 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BEF7D026 | 8/31/2020 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BEF7D027 | 8/31/2020 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BEF7D028 | 8/31/2020 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BEF7D045 | 11/30/2020 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BEF7D046 | 11/30/2020 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BEF7E005 | 1/31/2021 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7D005 | 3/31/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7D029 | 8/31/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7D030 | 8/31/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7D048 | 11/30/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7E001 | 12/31/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7E002 | 12/31/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7E003 | 12/31/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7E004 | 12/31/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BP02C051 | 10/31/2019 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BP02C052 | 10/31/2019 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D060 | 11/30/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D061 | 11/30/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D062 | 11/30/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D063 | 11/30/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BX35D024 | 1/31/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D064 | 11/30/2020 |
| 13668-117-10 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 count | BEF8D059 | 11/30/2020 |
| 13668-117-10 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 count | BEF8E004 | 1/31/2021 |
| 13668-117-10 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 count | BEF8E005 | 1/31/2021 |
| 13668-118-30 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 30 count | BEF6D054 | 8/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D100 | 11/30/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D101 | 11/30/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D102 | 11/30/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6E001 | 12/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6E002 | 12/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6E003 | 12/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6E004 | 12/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6E008 | 12/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6E009 | 12/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6E010 | 12/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6E011 | 12/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6E012 | 12/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BP04D012 | 12/31/2019 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BP04D013 | 12/31/2019 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BP04C092 | 10/31/2019 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D012 | 3/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D013 | 3/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D060 | 9/30/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D061 | 9/30/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D063 | 9/30/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D076 | 10/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D077 | 10/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D078 | 10/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D079 | 10/31/2020 |
| 13668-118-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | BP04C094 | 10/31/2019 |
| 13668-118-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | BEF6D096 | 11/30/2020 |
| 13668-118-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | BEF6D097 | 11/30/2020 |
| 13668-118-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | BEF6D098 | 11/30/2020 |
| 13668-118-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | BEF6D099 | 11/30/2020 |
| 13668-118-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | BEF6E005 | 12/31/2020 |
| 13668-118-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | BEF6E006 | 12/31/2020 |
| 13668-118-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | BP04D016 | 2/29/2020 |
| 13668-118-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | BP04D017 | 2/29/2020 |
| 13668-118-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | BP04D018 | 2/29/2020 |
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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