By Erin Smith
A recall for a popular blood pressure and heart failure medication has been expanded to include more medication that contain Losartan as an ingredient. The medications are being recalled due to impurities found in the Losartan that are a potential carcinogen.
The US Food and Drug Administration said the impurity is N-Nitroso-N-methyl-4-aminobutyric acid or NMBA. The company, Torrent Pharmaceuticals Limited, has voluntarily issued a recall of 87 lots of Losartan tablets made by the Hetero Labs Limited in Indiana.
According to a release regarding the recall, Losaratan is used to treat a variety of medical conditions including hypertension (high blood pressure), certain types of heart disease, and nephropathy is Type 2 diabetic patients.
Products being recalled include:
| NDC | Finished Product Strength and Package Count | Batch Number | Expiration Date |
|---|---|---|---|
| 13668-113-90 | Losartan Potassium Tablets, USP 25mg, 90 count | 4DU1E005 | 1/31/2021 |
| 13668-113-90 | Losartan Potassium Tablets, USP 25mg, 90 count | 4DU1E006 | 1/31/2021 |
| 13668-113-90 | Losartan Potassium Tablets, USP 25mg, 90 count | 4DU1E008 | 1/31/2021 |
| 13668-113-10 | Losartan Potassium Tablets, USP 25mg, 1000 count | 4DU1E007 | 1/31/2021 |
| 13668-409-30 | Losartan Potassium Tablets, USP 50mg, 30 count | 4DU2D077 | 10/31/2020 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2D087 | 10/31/2020 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2E023 | 1/31/2021 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2E024 | 1/31/2021 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2E026 | 1/31/2021 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2E027 | 1/31/2021 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2E028 | 1/31/2021 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2E029 | 1/31/2021 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4DU2E020 | 1/31/2021 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4O50E007 | 8/31/2021 |
| 13668-409-90 | Losartan Potassium Tablets, USP 50mg, 90 count | 4O50E008 | 8/31/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D067 | 9/30/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D069 | 9/30/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D063 | 9/30/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D064 | 9/30/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D065 | 9/30/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D066 | 9/30/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D084 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D085 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D083 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D082 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D072 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D077 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D078 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D079 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D081 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D080 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D070 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D073 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D074 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D075 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D086 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D088 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2D089 | 10/31/2020 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E019 | 1/31/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E021 | 1/31/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E022 | 1/31/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E025 | 1/31/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E032 | 2/28/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E033 | 2/28/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E034 | 2/28/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E035 | 2/28/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E036 | 2/28/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E037 | 2/28/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E038 | 2/28/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E039 | 2/28/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E041 | 2/28/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E103 | 6/30/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E101 | 6/30/2021 |
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E102 | 6/30/2021 |
| 13668-115-90 | Losartan Potassium Tablets, USP 100mg, 90 count | 4DU3E014 | 1/31/2021 |
| 13668-115-90 | Losartan Potassium Tablets, USP 100mg, 90 count | 4DU3E015 | 1/31/2021 |
| 13668-115-90 | Losartan Potassium Tablets, USP 100mg, 90 count | 4DU3E065 | 7/31/2021 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3D018 | 11/30/2020 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3E062 | 6/30/2021 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3E063 | 6/30/2021 |
| 13668-116-30 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count | BEF7D017 | 6/30/2020 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BEF7D010 | 4/30/2020 |
| 13668-116-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BEF7D011 | 4/30/2020 |
| 13668-116-90 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BEF7D018 | 6/30/2020 |
| 13668-116-90 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BEF7D009 | 4/30/2020 |
| 13668-116-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | 4P02E002 | 1/31/2021 |
| 13668-116-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | 4P02E003 | 1/31/2021 |
| 13668-116-90 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | 4P02E004 | 1/31/2021 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7D008 | 4/30/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7D022 | 8/31/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7D012 | 4/30/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7D013 | 4/30/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | BEF7D049 | 11/30/2020 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | 4P02E005 | 1/31/2021 |
| 13668-116-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count | 4P02E006 | 1/31/2021 |
| 13668-117-30 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 30 count | BEF8D058 | 11/30/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D023 | 4/30/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D024 | 4/30/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D025 | 4/30/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D009 | 3/31/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D010 | 3/31/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D011 | 3/31/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D012 | 3/31/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D013 | 3/31/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D054 | 10/31/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D055 | 10/31/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D056 | 10/31/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D057 | 11/30/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D007 | 3/31/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D008 | 3/31/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D020 | 4/30/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D021 | 4/30/2020 |
| 13668-117-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count | BEF8D022 | 4/30/2020 |
| 13668-118-30 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 30 count | BEF6D038 | 4/30/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D030 | 4/30/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D031 | 4/30/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D047 | 7/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90count | BEF6D048 | 7/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D049 | 7/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D050 | 7/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D051 | 7/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D082 | 10/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D083 | 10/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D084 | 10/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D085 | 10/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D086 | 10/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | BEF6D087 | 10/31/2020 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | 4P04E003 | 1/31/2021 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | 4P04E004 | 1/31/2021 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | 4P04E005 | 1/31/2021 |
| 13668-118-90 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count | 4P04E006 | 1/31/2021 |
| 13668-118-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | 4P04E007 | 1/31/2021 |
| 13668-118-10 | Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | 4P04E008 | 1/31/2021 |
| 13668-118-10 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count | 4P04E009 | 1/31/2021 |
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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) or via email at Medinfo.Torrent@apcerls.com.
About Author
