Medications & Supplements/Prescription Drugs

Torrent Pharma Inc.: Losartan Potassium Tablets Recalled for Excessive Impurity (NMBA)

Agency Publication Date: April 10, 2019

Summary

Torrent Pharma Inc. has recalled over 1 million bottles of Losartan Potassium and Losartan Potassium / Hydrochlorothiazide combination tablets, which are prescription medications used to treat high blood pressure. Testing by the FDA found that certain batches contain N-Methylnitrosobutyric acid (NMBA), an impurity that exceeds the acceptable daily intake limits. These products were distributed nationwide across the United States and Puerto Rico.

Risk

The presence of NMBA in these tablets is a concern because this impurity is classified as a potential human carcinogen, meaning long-term exposure above safety levels could increase the risk of cancer.

What You Should Do

Identify your medication by checking the name, strength, and NDC number on your prescription bottle for 'Losartan Potassium' (25mg, 50mg, 100mg) or 'Losartan Potassium / Hydrochlorothiazide' (50mg/12.5mg, 100mg/12.5mg, 100mg/25mg).
Check the bottle label for the following specific lot numbers and expiration dates: Losartan 25mg (Lots 4DU1E005, 4DU1E006, 4DU1E008, 4DU1E007, Exp 1/31/2021); Losartan 50mg (Lots 4DU2D077, 4DU2D087, 4DU2E023, 4DU2E024, 4DU2E026, 4DU2E027, 4DU2E028, 4DU2E029, 4DU2E020, 4O50E007, 4O50E008, 4DU2D067, 4DU2D069, 4DU2D063, 4DU2D064, 4DU2D065, 4DU2D066, 4DU2D084, 4DU2D085, 4DU2D083, 4DU2D082, 4DU2D072, 4DU2D078, 4DU2D079, 4DU2D081, 4DU2D080, 4DU2D070, 4DU2D073, 4DU2D074, 4DU2D075, 4DU2D086, 4DU2D088, 4DU2D089, 4DU2E019, 4DU2E021, 4DU2E022, 4DU2E025, 4DU2E032, 4DU2E033, 4DU2E034, 4DU2E035, 4DU2E036, 4DU2E037, 4DU2E038, 4DU2E039, 4DU2E041, 4DU2E103, 4DU2E101, 4DU2E102).
Continue checking for these additional lots: Losartan 100mg (Lots 4DU3E014, 4DU3E015, 4DU3E065, 4DU3D018, 4DU3E062, 4DU3E063); Losartan/HCTZ 50/12.5mg (Lots BEF7D017, BEF7D010, BEF7D011, BEF7D018, BEF7D009, 4P02E002, 4P02E003, 4P02E004, BEF7D008, BEF7D012, BEF7D013, BEF7D022, BEF7D049, 4P02E005, 4P02E006); Losartan/HCTZ 100/12.5mg (Lots BEF8D058, BEF8D009, BEF8D010, BEF8D011, BEF8D012, BEF8D013, BEF8D007, BEF8D008, BEF8D023, BEF8D024, BEF8D025, BEF8D020, BEF8D021, BEF8D022, BEF8D054, BEF8D055, BEF8D056, BEF8D057); Losartan/HCTZ 100/25mg (Lots BEF6D038, BEF6D030, BEF6D031, BEF6D047, BEF6D048, BEF6D049, BEF6D050, BEF6D051, BEF6D082, BEF6D083, BEF6D084, BEF6D085, BEF6D086, BEF6D087, 4P04E003, 4P04E004, 4P04E005, 4P04E006, 4P04E007, 4P04E008, 4P04E009).
Do NOT stop taking your medication without first speaking to your doctor or pharmacist. High blood pressure is a serious condition, and stopping your medication abruptly could pose a greater health risk than the impurity itself.
Contact your healthcare provider or pharmacist immediately to discuss a replacement or an alternative treatment if your lot is affected.
Return any unused recalled product to the pharmacy where you purchased it for a refund and contact Torrent Pharma Inc. for further instructions.
For further information or to report a concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Refund available for unused product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: LOSARTAN POTASSIUM TABLETS, USP, 25 mg

Model:

NDC: 13668-113-90

NDC: 13668-113-10

Lot Numbers:

4DU1E005 (Exp 1/31/2021)

4DU1E006 (Exp 1/31/2021)

4DU1E008 (Exp 1/31/2021)

4DU1E007 (Exp 1/31/2021)

Product: LOSARTAN POTASSIUM TABLETS, USP, 50 mg

Model:

NDC: 13668-409-30

NDC: 13668-409-90

NDC: 13668-409-10

Lot Numbers:

4DU2D077 (Exp 10/31/2020)

4DU2D087 (Exp 10/31/2020)

4DU2E023 (Exp 1/31/2021)

4DU2E024 (Exp 1/31/2021)

4DU2E026 (Exp 1/31/2021)

4DU2E027 (Exp 1/31/2021)

4DU2E028 (Exp 1/31/2021)

4DU2E029 (Exp 1/31/2021)

4DU2E020 (Exp 1/31/2021)

4O50E007 (Exp 8/31/2021)

4O50E008 (Exp 8/31/2021)

4DU2D067 (Exp 9/30/2020)

4DU2D069 (Exp 9/30/2020)

4DU2D063 (Exp 9/30/2020)

4DU2D064 (Exp 9/30/2020)

4DU2D065 (Exp 9/30/2020)

4DU2D066 (Exp 9/30/2020)

4DU2D084 (Exp 10/31/2020)

4DU2D085 (Exp 10/31/2020)

4DU2D083 (Exp 10/31/2020)

4DU2D082 (Exp 10/31/2020)

4DU2D072 (Exp 10/31/2020)

4DU2D078 (Exp 10/31/2020)

4DU2D079 (Exp 10/31/2020)

4DU2D081 (Exp 10/31/2020)

4DU2D080 (Exp 10/31/2020)

4DU2D070 (Exp 10/31/2020)

4DU2D073 (Exp 10/31/2020)

4DU2D074 (Exp 10/31/2020)

4DU2D075 (Exp 10/31/2020)

4DU2D086 (Exp 10/31/2020)

4DU2D088 (Exp 10/31/2020)

4DU2D089 (Exp 10/31/2020)

4DU2E019 (Exp 1/31/2021)

4DU2E021 (Exp 1/31/2021)

4DU2E022 (Exp 1/31/2021)

4DU2E025 (Exp 1/31/2021)

4DU2E032 (Exp 2/28/2021)

4DU2E033 (Exp 2/28/2021)

4DU2E034 (Exp 2/28/2021)

4DU2E035 (Exp 2/28/2021)

4DU2E036 (Exp 2/28/2021)

4DU2E037 (Exp 2/28/2021)

4DU2E038 (Exp 2/28/2021)

4DU2E039 (Exp 2/28/2021)

4DU2E041 (Exp 2/28/2021)

4DU2E103 (Exp 6/30/2021)

4DU2E101 (Exp 6/30/2021)

4DU2E102 (Exp 6/30/2021)

Product: LOSARTAN POTASSIUM TABLETS, USP, 100 mg

Model:

NDC: 13668-115-90

NDC: 13668-115-10

Lot Numbers:

4DU3E014 (Exp 1/31/2021)

4DU3E015 (Exp 1/31/2021)

4DU3E065 (Exp 7/31/2021)

4DU3D018 (Exp 11/30/2020)

4DU3E062 (Exp 6/30/2021)

4DU3E063 (Exp 6/30/2021)

Product: Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg

Model:

NDC: 13668-116-30

NDC: 13668-116-90

NDC: 13668-116-10

Lot Numbers:

BEF7D017 (Exp 6/30/2020)

BEF7D010 (Exp 4/30/2020)

BEF7D011 (Exp 4/30/2020)

BEF7D018 (Exp 6/30/2020)

BEF7D009 (Exp 4/30/2020)

4P02E002 (Exp 1/31/2021)

4P02E003 (Exp 1/31/2021)

4P02E004 (Exp 1/31/2021)

BEF7D008 (Exp 4/30/2020)

BEF7D012 (Exp 4/30/2020)

BEF7D013 (Exp 4/30/2020)

BEF7D022 (Exp 8/31/2020)

BEF7D049 (Exp 11/30/2020)

4P02E005 (Exp 1/31/2021)

4P02E006 (Exp 1/31/2021)

Product: Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg

Model:

NDC: 13668-117-30

NDC: 13668-117-90

Lot Numbers:

BEF8D058 (Exp 11/30/2020)

BEF8D009 (Exp 3/31/2020)

BEF8D010 (Exp 3/31/2020)

BEF8D011 (Exp 3/31/2020)

BEF8D012 (Exp 3/31/2020)

BEF8D013 (Exp 3/31/2020)

BEF8D007 (Exp 3/31/2020)

BEF8D008 (Exp 3/31/2020)

BEF8D023 (Exp 4/30/2020)

BEF8D024 (Exp 4/30/2020)

BEF8D025 (Exp 4/30/2020)

BEF8D020 (Exp 4/30/2020)

BEF8D021 (Exp 4/30/2020)

BEF8D022 (Exp 4/30/2020)

BEF8D054 (Exp 10/31/2020)

BEF8D055 (Exp 10/31/2020)

BEF8D056 (Exp 10/31/2020)

BEF8D057 (Exp 11/30/2020)

Product: Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg

Model:

NDC: 13668-118-30

NDC: 13668-118-90

NDC: 13668-118-10

Lot Numbers:

BEF6D038 (Exp 4/30/2020)

BEF6D030 (Exp 4/30/2020)

BEF6D031 (Exp 4/30/2020)

BEF6D047 (Exp 7/31/2020)

BEF6D048 (Exp 7/31/2020)

BEF6D049 (Exp 7/31/2020)

BEF6D050 (Exp 7/31/2020)

BEF6D051 (Exp 7/31/2020)

BEF6D082 (Exp 10/31/2020)

BEF6D083 (Exp 10/31/2020)

BEF6D084 (Exp 10/31/2020)

BEF6D085 (Exp 10/31/2020)

BEF6D086 (Exp 10/31/2020)

BEF6D087 (Exp 10/31/2020)

4P04E003 (Exp 1/31/2021)

4P04E004 (Exp 1/31/2021)

4P04E005 (Exp 1/31/2021)

4P04E006 (Exp 1/31/2021)

4P04E007 (Exp 1/31/2021)

4P04E008 (Exp 1/31/2021)

4P04E009 (Exp 1/31/2021)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82585

Status: Active

Manufacturer: Torrent Pharma Inc.

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 5 products (133,992 bottles; 476,340 bottles; 121,668 bottles; 172,296 bottles; 173,760 bottles)

Distributed To: Nationwide

Agency Last Updated: May 16, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify your medication by checking the name, strength, and NDC number on your prescription bottle for 'Losartan Potassium' (25mg, 50mg, 100mg) or 'Losartan Potassium / Hydrochlorothiazide' (50mg/12.5mg, 100mg/12.5mg, 100mg/25mg).

Check the bottle label for the following specific lot numbers and expiration dates: Losartan 25mg (Lots 4DU1E005, 4DU1E006, 4DU1E008, 4DU1E007, Exp 1/31/2021); Losartan 50mg (Lots 4DU2D077, 4DU2D087, 4DU2E023, 4DU2E024, 4DU2E026, 4DU2E027, 4DU2E028, 4DU2E029, 4DU2E020, 4O50E007, 4O50E008, 4DU2D067, 4DU2D069, 4DU2D063, 4DU2D064, 4DU2D065, 4DU2D066, 4DU2D084, 4DU2D085, 4DU2D083, 4DU2D082, 4DU2D072, 4DU2D078, 4DU2D079, 4DU2D081, 4DU2D080, 4DU2D070, 4DU2D073, 4DU2D074, 4DU2D075, 4DU2D086, 4DU2D088, 4DU2D089, 4DU2E019, 4DU2E021, 4DU2E022, 4DU2E025, 4DU2E032, 4DU2E033, 4DU2E034, 4DU2E035, 4DU2E036, 4DU2E037, 4DU2E038, 4DU2E039, 4DU2E041, 4DU2E103, 4DU2E101, 4DU2E102).

Continue checking for these additional lots: Losartan 100mg (Lots 4DU3E014, 4DU3E015, 4DU3E065, 4DU3D018, 4DU3E062, 4DU3E063); Losartan/HCTZ 50/12.5mg (Lots BEF7D017, BEF7D010, BEF7D011, BEF7D018, BEF7D009, 4P02E002, 4P02E003, 4P02E004, BEF7D008, BEF7D012, BEF7D013, BEF7D022, BEF7D049, 4P02E005, 4P02E006); Losartan/HCTZ 100/12.5mg (Lots BEF8D058, BEF8D009, BEF8D010, BEF8D011, BEF8D012, BEF8D013, BEF8D007, BEF8D008, BEF8D023, BEF8D024, BEF8D025, BEF8D020, BEF8D021, BEF8D022, BEF8D054, BEF8D055, BEF8D056, BEF8D057); Losartan/HCTZ 100/25mg (Lots BEF6D038, BEF6D030, BEF6D031, BEF6D047, BEF6D048, BEF6D049, BEF6D050, BEF6D051, BEF6D082, BEF6D083, BEF6D084, BEF6D085, BEF6D086, BEF6D087, 4P04E003, 4P04E004, 4P04E005, 4P04E006, 4P04E007, 4P04E008, 4P04E009).

Do NOT stop taking your medication without first speaking to your doctor or pharmacist. High blood pressure is a serious condition, and stopping your medication abruptly could pose a greater health risk than the impurity itself.

Contact your healthcare provider or pharmacist immediately to discuss a replacement or an alternative treatment if your lot is affected.

Return any unused recalled product to the pharmacy where you purchased it for a refund and contact Torrent Pharma Inc. for further instructions.

For further information or to report a concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: LOSARTAN POTASSIUM TABLETS, USP, 25 mg

Model:

NDC: 13668-113-90

NDC: 13668-113-10

Lot Numbers:

4DU1E005 (Exp 1/31/2021)

4DU1E006 (Exp 1/31/2021)

4DU1E008 (Exp 1/31/2021)

4DU1E007 (Exp 1/31/2021)

Product: LOSARTAN POTASSIUM TABLETS, USP, 50 mg

Model:

NDC: 13668-409-30

NDC: 13668-409-90

NDC: 13668-409-10

Lot Numbers:

4DU2D077 (Exp 10/31/2020)

4DU2D087 (Exp 10/31/2020)

4DU2E023 (Exp 1/31/2021)

4DU2E024 (Exp 1/31/2021)

4DU2E026 (Exp 1/31/2021)

4DU2E027 (Exp 1/31/2021)

4DU2E028 (Exp 1/31/2021)

4DU2E029 (Exp 1/31/2021)

4DU2E020 (Exp 1/31/2021)

4O50E007 (Exp 8/31/2021)

4O50E008 (Exp 8/31/2021)

4DU2D067 (Exp 9/30/2020)

4DU2D069 (Exp 9/30/2020)

4DU2D063 (Exp 9/30/2020)

4DU2D064 (Exp 9/30/2020)

4DU2D065 (Exp 9/30/2020)

4DU2D066 (Exp 9/30/2020)

4DU2D084 (Exp 10/31/2020)

4DU2D085 (Exp 10/31/2020)

4DU2D083 (Exp 10/31/2020)

4DU2D082 (Exp 10/31/2020)

4DU2D072 (Exp 10/31/2020)

4DU2D078 (Exp 10/31/2020)

4DU2D079 (Exp 10/31/2020)

4DU2D081 (Exp 10/31/2020)

4DU2D080 (Exp 10/31/2020)

4DU2D070 (Exp 10/31/2020)

4DU2D073 (Exp 10/31/2020)

4DU2D074 (Exp 10/31/2020)

4DU2D075 (Exp 10/31/2020)

4DU2D086 (Exp 10/31/2020)

4DU2D088 (Exp 10/31/2020)

4DU2D089 (Exp 10/31/2020)

4DU2E019 (Exp 1/31/2021)

4DU2E021 (Exp 1/31/2021)

4DU2E022 (Exp 1/31/2021)

4DU2E025 (Exp 1/31/2021)

4DU2E032 (Exp 2/28/2021)

4DU2E033 (Exp 2/28/2021)

4DU2E034 (Exp 2/28/2021)

4DU2E035 (Exp 2/28/2021)

4DU2E036 (Exp 2/28/2021)

4DU2E037 (Exp 2/28/2021)

4DU2E038 (Exp 2/28/2021)

4DU2E039 (Exp 2/28/2021)

4DU2E041 (Exp 2/28/2021)

4DU2E103 (Exp 6/30/2021)

4DU2E101 (Exp 6/30/2021)

4DU2E102 (Exp 6/30/2021)

Product: LOSARTAN POTASSIUM TABLETS, USP, 100 mg

Model:

NDC: 13668-115-90

NDC: 13668-115-10

Lot Numbers:

4DU3E014 (Exp 1/31/2021)

4DU3E015 (Exp 1/31/2021)

4DU3E065 (Exp 7/31/2021)

4DU3D018 (Exp 11/30/2020)

4DU3E062 (Exp 6/30/2021)

4DU3E063 (Exp 6/30/2021)

Product: Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg

Model:

NDC: 13668-116-30

NDC: 13668-116-90

NDC: 13668-116-10

Lot Numbers:

BEF7D017 (Exp 6/30/2020)

BEF7D010 (Exp 4/30/2020)

BEF7D011 (Exp 4/30/2020)

BEF7D018 (Exp 6/30/2020)

BEF7D009 (Exp 4/30/2020)

4P02E002 (Exp 1/31/2021)

4P02E003 (Exp 1/31/2021)

4P02E004 (Exp 1/31/2021)

BEF7D008 (Exp 4/30/2020)

BEF7D012 (Exp 4/30/2020)

BEF7D013 (Exp 4/30/2020)

BEF7D022 (Exp 8/31/2020)

BEF7D049 (Exp 11/30/2020)

4P02E005 (Exp 1/31/2021)

4P02E006 (Exp 1/31/2021)

Product: Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg

Model:

NDC: 13668-117-30

NDC: 13668-117-90

Lot Numbers:

BEF8D058 (Exp 11/30/2020)

BEF8D009 (Exp 3/31/2020)

BEF8D010 (Exp 3/31/2020)

BEF8D011 (Exp 3/31/2020)

BEF8D012 (Exp 3/31/2020)

BEF8D013 (Exp 3/31/2020)

BEF8D007 (Exp 3/31/2020)

BEF8D008 (Exp 3/31/2020)

BEF8D023 (Exp 4/30/2020)

BEF8D024 (Exp 4/30/2020)

BEF8D025 (Exp 4/30/2020)

BEF8D020 (Exp 4/30/2020)

BEF8D021 (Exp 4/30/2020)

BEF8D022 (Exp 4/30/2020)

BEF8D054 (Exp 10/31/2020)

BEF8D055 (Exp 10/31/2020)

BEF8D056 (Exp 10/31/2020)

BEF8D057 (Exp 11/30/2020)

Product: Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg

Model:

NDC: 13668-118-30

NDC: 13668-118-90

NDC: 13668-118-10

Lot Numbers:

BEF6D038 (Exp 4/30/2020)

BEF6D030 (Exp 4/30/2020)

BEF6D031 (Exp 4/30/2020)

BEF6D047 (Exp 7/31/2020)

BEF6D048 (Exp 7/31/2020)

BEF6D049 (Exp 7/31/2020)

BEF6D050 (Exp 7/31/2020)

BEF6D051 (Exp 7/31/2020)

BEF6D082 (Exp 10/31/2020)

BEF6D083 (Exp 10/31/2020)

BEF6D084 (Exp 10/31/2020)

BEF6D085 (Exp 10/31/2020)

BEF6D086 (Exp 10/31/2020)

BEF6D087 (Exp 10/31/2020)

4P04E003 (Exp 1/31/2021)

4P04E004 (Exp 1/31/2021)

4P04E005 (Exp 1/31/2021)

4P04E006 (Exp 1/31/2021)

4P04E007 (Exp 1/31/2021)

4P04E008 (Exp 1/31/2021)

4P04E009 (Exp 1/31/2021)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82585

Status: Active

Manufacturer: Torrent Pharma Inc.

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 5 products (133,992 bottles; 476,340 bottles; 121,668 bottles; 172,296 bottles; 173,760 bottles)

Distributed To: Nationwide

Agency Last Updated: May 16, 2019