Medications & Supplements/Prescription Drugs

Torrent Pharma Inc.: Losartan Potassium Tablets Recalled for Excessive Impurity Levels

Agency Publication Date: May 1, 2019

Summary

Torrent Pharma Inc. has voluntarily recalled approximately 882,936 bottles of Losartan Potassium and Losartan Potassium/Hydrochlorothiazide tablets because they contain an impurity called N-Methylnitrosobutyric acid (NMBA) above acceptable daily intake levels. These prescription medications, used to treat high blood pressure, were sold in various strengths and bottle sizes including 30, 90, and 1000-count containers. Consumers should not stop taking their medication without first consulting their doctor, as the risk of suddenly stopping blood pressure treatment may be greater than the risk from the impurity.

Risk

The tablets contain NMBA, a known impurity that is classified as a potential human carcinogen. While no immediate injuries have been reported, long-term exposure to this substance above the interim daily intake limit may increase the risk of developing cancer.

What You Should Do

Check your prescription bottle for the following product names and NDC numbers: Losartan Potassium (13668-113, 13668-409, 13668-115) or Losartan Potassium/Hydrochlorothiazide (13668-116, 13668-117, 13668-118).
Verify if your bottle matches specific affected lot numbers such as BDK1C003, 4DU2D040, 4DU3E016, BEF7D047, or BX35D024, with expiration dates ranging from July 2019 through August 2021.
Do NOT stop taking your medication immediately; contact your pharmacist or physician for a replacement or to discuss an alternative treatment plan, as suddenly stopping high blood pressure medication can pose serious health risks.
Return any unused product from the affected lots to your pharmacy for a refund and to ensure proper disposal.
Contact Torrent Pharma Inc. directly at 1-800-912-9561 for further instructions regarding this recall.
If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Refund or pharmacy replacement following physician consultation.

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 (90-count)

Model:

NDC: 13668-113-90

Lot Numbers:

BDK1C003 (Exp 07/31/2019)

Product: Losartan Potassium Tablets, USP, 25 mg (1000-count)

Model:

NDC: 13668-113-10

Lot Numbers:

BDK1C002 (Exp 07/31/2019)

4DU1D004 (Exp 12/31/2019)

4DU1D005 (Exp 12/31/2019)

4DU1D006 (Exp 12/31/2019)

Product: Losartan Potassium Tablets, USP, 50 mg (90-count)

Model:

NDC: 13668-409-90

Lot Numbers:

4DU2D005 (Exp 12/31/2019)

4DU2D006 (Exp 12/31/2019)

4DU2D026 (Exp 3/31/2020)

4DU2D027 (Exp 3/31/2020)

4DU2D029 (Exp 3/31/2020)

4DU2E007 (Exp 12/31/2020)

Product: Losartan Potassium Tablets, USP, 50 mg (1000-count)

Model:

NDC: 13668-409-10

Lot Numbers:

4DU2D017 (Exp 2/29/2020)

4DU2D025 (Exp 3/31/2020)

4DU2D028 (Exp 3/31/2020)

4DU2D040 (Exp 8/31/2020)

4DU2D041 (Exp 8/31/2020)

4DU2D042 (Exp 8/31/2020)

4DU2D045 (Exp 8/31/2020)

4DU2D046 (Exp 8/31/2020)

4DU2D047 (Exp 8/31/2020)

4DU2D048 (Exp 8/31/2020)

BDK2E001 (Exp 12/31/2020)

4DU2E042 (Exp 2/28/2021)

4DU2E044 (Exp 2/28/2021)

BDK2E012 (Exp 8/31/2021)

BDK2E013 (Exp 8/31/2021)

Product: Losartan Potassium Tablets, USP, 100 mg (90-count)

Model:

NDC: 13668-115-90

Lot Numbers:

4DU3E016 (Exp 01/31/2021)

Product: Losartan Potassium Tablets, USP, 100 mg (1000-count)

Model:

NDC: 13668-115-10

Lot Numbers:

4DU3C012 (Exp 7/31/2019)

4DU3C015 (Exp 8/31/2019)

4DU3C016 (Exp 8/31/2019)

4DU3C017 (Exp 8/31/2019)

4DU3C031 (Exp 9/30/2019)

4DU3D007 (Exp 1/31/2020)

4DU3D008 (Exp 1/31/2020)

4DU3E017 (Exp 1/31/2021)

4DU3E019 (Exp 2/28/2021)

Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg (30, 90, 1000-count)

Model:

NDC: 13668-116-30

NDC: 13668-116-90

NDC: 13668-116-10

Lot Numbers:

BP02C051 (Exp 10/31/2019)

BP02D005 (Exp 12/31/2019)

BEF7D047 (Exp 11/30/2020)

BP02C050 (Exp 10/31/2019)

BP02D006 (Exp 12/31/2019)

BP02D007 (Exp 12/31/2019)

BP02D012 (Exp 1/31/2020)

BEF7D003 (Exp 3/31/2020)

BEF7D026 (Exp 8/31/2020)

BEF7D027 (Exp 8/31/2020)

BEF7D028 (Exp 8/31/2020)

BEF7D045 (Exp 11/30/2020)

BEF7D046 (Exp 11/30/2020)

BEF7E005 (Exp 1/31/2021)

BP02C052 (Exp 10/31/2019)

BEF7D005 (Exp 3/31/2020)

BEF7D029 (Exp 8/31/2020)

BEF7D030 (Exp 8/31/2020)

BEF7D048 (Exp 11/30/2020)

BEF7E001 (Exp 12/31/2020)

BEF7E002 (Exp 12/31/2020)

BEF7E003 (Exp 12/31/2020)

BEF7E004 (Exp 12/31/2020)

Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg (90, 1000-count)

Model:

NDC: 13668-117-90

NDC: 13668-117-10

Lot Numbers:

BX35D024 (Exp 1/31/2020)

BEF8D060 (Exp 11/30/2020)

BEF8D061 (Exp 11/30/2020)

BEF8D062 (Exp 11/30/2020)

BEF8D063 (Exp 11/30/2020)

BEF8D064 (Exp 11/30/2020)

BEF8D059 (Exp 11/30/2020)

BEF8E004 (Exp 1/31/2021)

BEF8E005 (Exp 1/31/2021)

Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg (30, 90, 1000-count)

Model:

NDC: 13668-118-30

NDC: 13668-118-90

NDC: 13668-118-10

Lot Numbers:

BEF6D054 (Exp 8/31/2020)

BP04C092 (Exp 10/31/2019)

BP04D012 (Exp 12/31/2019)

BP04D013 (Exp 12/31/2019)

BEF6D012 (Exp 3/31/2020)

BEF6D013 (Exp 3/31/2020)

BEF6D060 (Exp 9/30/2020)

BEF6D061 (Exp 9/30/2020)

BEF6D063 (Exp 9/30/2020)

BEF6D076 (Exp 10/31/2020)

BEF6D077 (Exp 10/31/2020)

BEF6D078 (Exp 10/31/2020)

BEF6D079 (Exp 10/31/2020)

BEF6D100 (Exp 11/30/2020)

BEF6D101 (Exp 11/30/2020)

BEF6D102 (Exp 11/30/2020)

BEF6E001 (Exp 12/31/2020)

BEF6E002 (Exp 12/31/2020)

BEF6E003 (Exp 12/31/2020)

BEF6E004 (Exp 12/31/2020)

BEF6E008 (Exp 12/31/2020)

BEF6E009 (Exp 12/31/2020)

BEF6E010 (Exp 12/31/2020)

BEF6E011 (Exp 12/31/2020)

BEF6E012 (Exp 12/31/2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82661

Status: Active

Manufacturer: Torrent Pharma Inc.

Sold By: Retail Pharmacies

Manufactured In: India, United States

Units Affected: 6 products (28,464 bottles; 164,424 bottles; 65,184 bottles; 331,764 bottles; 54,084 bottles; 239,016 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

Check your prescription bottle for the following product names and NDC numbers: Losartan Potassium (13668-113, 13668-409, 13668-115) or Losartan Potassium/Hydrochlorothiazide (13668-116, 13668-117, 13668-118).

Verify if your bottle matches specific affected lot numbers such as BDK1C003, 4DU2D040, 4DU3E016, BEF7D047, or BX35D024, with expiration dates ranging from July 2019 through August 2021.

Do NOT stop taking your medication immediately; contact your pharmacist or physician for a replacement or to discuss an alternative treatment plan, as suddenly stopping high blood pressure medication can pose serious health risks.

Return any unused product from the affected lots to your pharmacy for a refund and to ensure proper disposal.

Contact Torrent Pharma Inc. directly at 1-800-912-9561 for further instructions regarding this recall.

If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Losartan Potassium Tablets, USP, 25 mg (90-count)

Model:

NDC: 13668-113-90

Lot Numbers:

BDK1C003 (Exp 07/31/2019)

Product: Losartan Potassium Tablets, USP, 25 mg (1000-count)

Model:

NDC: 13668-113-10

Lot Numbers:

BDK1C002 (Exp 07/31/2019)

4DU1D004 (Exp 12/31/2019)

4DU1D005 (Exp 12/31/2019)

4DU1D006 (Exp 12/31/2019)

Product: Losartan Potassium Tablets, USP, 50 mg (90-count)

Model:

NDC: 13668-409-90

Lot Numbers:

4DU2D005 (Exp 12/31/2019)

4DU2D006 (Exp 12/31/2019)

4DU2D026 (Exp 3/31/2020)

4DU2D027 (Exp 3/31/2020)

4DU2D029 (Exp 3/31/2020)

4DU2E007 (Exp 12/31/2020)

Product: Losartan Potassium Tablets, USP, 50 mg (1000-count)

Model:

NDC: 13668-409-10

Lot Numbers:

4DU2D017 (Exp 2/29/2020)

4DU2D025 (Exp 3/31/2020)

4DU2D028 (Exp 3/31/2020)

4DU2D040 (Exp 8/31/2020)

4DU2D041 (Exp 8/31/2020)

4DU2D042 (Exp 8/31/2020)

4DU2D045 (Exp 8/31/2020)

4DU2D046 (Exp 8/31/2020)

4DU2D047 (Exp 8/31/2020)

4DU2D048 (Exp 8/31/2020)

BDK2E001 (Exp 12/31/2020)

4DU2E042 (Exp 2/28/2021)

4DU2E044 (Exp 2/28/2021)

BDK2E012 (Exp 8/31/2021)

BDK2E013 (Exp 8/31/2021)

Product: Losartan Potassium Tablets, USP, 100 mg (90-count)

Model:

NDC: 13668-115-90

Lot Numbers:

4DU3E016 (Exp 01/31/2021)

Product: Losartan Potassium Tablets, USP, 100 mg (1000-count)

Model:

NDC: 13668-115-10

Lot Numbers:

4DU3C012 (Exp 7/31/2019)

4DU3C015 (Exp 8/31/2019)

4DU3C016 (Exp 8/31/2019)

4DU3C017 (Exp 8/31/2019)

4DU3C031 (Exp 9/30/2019)

4DU3D007 (Exp 1/31/2020)

4DU3D008 (Exp 1/31/2020)

4DU3E017 (Exp 1/31/2021)

4DU3E019 (Exp 2/28/2021)

Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg (30, 90, 1000-count)

Model:

NDC: 13668-116-30

NDC: 13668-116-90

NDC: 13668-116-10

Lot Numbers:

BP02C051 (Exp 10/31/2019)

BP02D005 (Exp 12/31/2019)

BEF7D047 (Exp 11/30/2020)

BP02C050 (Exp 10/31/2019)

BP02D006 (Exp 12/31/2019)

BP02D007 (Exp 12/31/2019)

BP02D012 (Exp 1/31/2020)

BEF7D003 (Exp 3/31/2020)

BEF7D026 (Exp 8/31/2020)

BEF7D027 (Exp 8/31/2020)

BEF7D028 (Exp 8/31/2020)

BEF7D045 (Exp 11/30/2020)

BEF7D046 (Exp 11/30/2020)

BEF7E005 (Exp 1/31/2021)

BP02C052 (Exp 10/31/2019)

BEF7D005 (Exp 3/31/2020)

BEF7D029 (Exp 8/31/2020)

BEF7D030 (Exp 8/31/2020)

BEF7D048 (Exp 11/30/2020)

BEF7E001 (Exp 12/31/2020)

BEF7E002 (Exp 12/31/2020)

BEF7E003 (Exp 12/31/2020)

BEF7E004 (Exp 12/31/2020)

Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg (90, 1000-count)

Model:

NDC: 13668-117-90

NDC: 13668-117-10

Lot Numbers:

BX35D024 (Exp 1/31/2020)

BEF8D060 (Exp 11/30/2020)

BEF8D061 (Exp 11/30/2020)

BEF8D062 (Exp 11/30/2020)

BEF8D063 (Exp 11/30/2020)

BEF8D064 (Exp 11/30/2020)

BEF8D059 (Exp 11/30/2020)

BEF8E004 (Exp 1/31/2021)

BEF8E005 (Exp 1/31/2021)

Product: Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg (30, 90, 1000-count)

Model:

NDC: 13668-118-30

NDC: 13668-118-90

NDC: 13668-118-10

Lot Numbers:

BEF6D054 (Exp 8/31/2020)

BP04C092 (Exp 10/31/2019)

BP04D012 (Exp 12/31/2019)

BP04D013 (Exp 12/31/2019)

BEF6D012 (Exp 3/31/2020)

BEF6D013 (Exp 3/31/2020)

BEF6D060 (Exp 9/30/2020)

BEF6D061 (Exp 9/30/2020)

BEF6D063 (Exp 9/30/2020)

BEF6D076 (Exp 10/31/2020)

BEF6D077 (Exp 10/31/2020)

BEF6D078 (Exp 10/31/2020)

BEF6D079 (Exp 10/31/2020)

BEF6D100 (Exp 11/30/2020)

BEF6D101 (Exp 11/30/2020)

BEF6D102 (Exp 11/30/2020)

BEF6E001 (Exp 12/31/2020)

BEF6E002 (Exp 12/31/2020)

BEF6E003 (Exp 12/31/2020)

BEF6E004 (Exp 12/31/2020)

BEF6E008 (Exp 12/31/2020)

BEF6E009 (Exp 12/31/2020)

BEF6E010 (Exp 12/31/2020)

BEF6E011 (Exp 12/31/2020)

BEF6E012 (Exp 12/31/2020)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82661

Status: Active

Manufacturer: Torrent Pharma Inc.

Sold By: Retail Pharmacies

Manufactured In: India, United States

Units Affected: 6 products (28,464 bottles; 164,424 bottles; 65,184 bottles; 331,764 bottles; 54,084 bottles; 239,016 bottles)

Distributed To: Nationwide

Agency Last Updated: May 16, 2019