Medications & Supplements/Prescription Drugs

Torrent Pharma Inc.: Losartan Potassium and Combination Tablets Recalled for Impurity Presence

Agency Publication Date: February 15, 2019

Summary

Torrent Pharma Inc. has recalled 229,896 bottles of Losartan Potassium and Losartan Potassium/Hydrochlorothiazide tablets (prescribed for high blood pressure) due to the presence of an impurity called NDEA. Laboratory testing confirmed the presence of this substance above safe daily intake levels in the active ingredient used to make these drugs. The recall affects several strengths and bottle sizes distributed nationwide in the United States and Puerto Rico. This is a voluntary recall initiated by the manufacturer following the discovery of the contamination.

Risk

The tablets contain N-nitrosodimethylamine (NDEA), an impurity that is classified as a probable human carcinogen. Continued use of the medication with levels above the interim acceptable limit of 0.083 parts per million may increase the risk of cancer over long-term exposure.

What You Should Do

Check your medication bottles for the following NDC numbers: 13668-115-30, 13668-115-90, 13668-115-10, 13668-409-30, 13668-409-90, 13668-409-10, 13668-113-90, 13668-117-90, 13668-117-10, 13668-116-90, or 13668-116-10.
Verify if your specific lot is affected: for 100mg Losartan, check for lots BO31C016, 4DK3C004, 4DK3C005, 4DU3C040, 4DU3E049, or 4DU3E050; for 50mg, check lots 4L67C035, 4L67C036, or 4O50C005; for 25mg, check lot 4O49C013; for combination tablets, check lots BX35C020, BX35C049, BX35C022, BX35C023, BP02C008, or BEF7D006.
Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking the medication, as suddenly stopping blood pressure medicine can pose health risks.
Return any unused, affected product to your pharmacy to receive a refund.
Contact Torrent Pharma Inc. if you have further questions or need assistance with the return process at their distributor location: 1803 Whites Rd Ste 1, Kalamazoo, Michigan.
For additional information or to report a problem, 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

Healthcare guidance and product refund

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, 100 mg (30, 90, or 1000-count)

Model:

NDC: 13668-115-30

NDC: 13668-115-90

NDC: 13668-115-10

Lot Numbers:

BO31C016 (Exp 04/2019)

4DK3C004 (Exp 04/2019)

4DK3C005 (Exp 04/2019)

4DU3C040 (Exp 10/2019)

4DU3E049 (Exp 05/2021)

4DU3E050 (Exp 05/2021)

Date Ranges: 04/2019, 10/2019, 05/2021

Product: LOSARTAN POTASSIUM TABLETS, USP, 50 mg (30, 90, or 1000-count)

Model:

NDC: 13668-409-30

NDC: 13668-409-90

NDC: 13668-409-10

Lot Numbers:

4L67C035 (Exp 10/2019)

4L67C036 (Exp 10/2019)

4O50C005 (Exp 11/2019)

Date Ranges: 10/2019, 11/2019

Product: LOSARTAN POTASSIUM TABLETS, USP, 25 mg (90-count)

Model:

NDC: 13668-113-90

Lot Numbers:

4O49C013 (Exp 09/2019)

Date Ranges: 09/2019

Product: LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg (90 or 1000-count)

Model:

NDC: 13668-117-90

NDC: 13668-117-10

Lot Numbers:

BX35C020 (Exp 05/2019)

BX35C049 (Exp 08/2019)

BX35C022 (Exp 05/2019)

BX35C023 (Exp 05/2019)

Date Ranges: 05/2019, 08/2019

Product: LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg (90 or 1000-count)

Model:

NDC: 13668-116-90

NDC: 13668-116-10

Lot Numbers:

BP02C008 (Exp 03/2019)

BEF7D006 (Exp 03/2020)

Date Ranges: 03/2019, 03/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81838

Status: Active

Manufacturer: Torrent Pharma Inc.

Sold By: pharmacies nationwide

Manufactured In: United States, India

Units Affected: 5 products (83,016 bottles; 65,832 bottles; 43,416 bottles; 18,852 bottles; 18,780 bottles)

Distributed To: Nationwide

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 medication bottles for the following NDC numbers: 13668-115-30, 13668-115-90, 13668-115-10, 13668-409-30, 13668-409-90, 13668-409-10, 13668-113-90, 13668-117-90, 13668-117-10, 13668-116-90, or 13668-116-10.

Verify if your specific lot is affected: for 100mg Losartan, check for lots BO31C016, 4DK3C004, 4DK3C005, 4DU3C040, 4DU3E049, or 4DU3E050; for 50mg, check lots 4L67C035, 4L67C036, or 4O50C005; for 25mg, check lot 4O49C013; for combination tablets, check lots BX35C020, BX35C049, BX35C022, BX35C023, BP02C008, or BEF7D006.

Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking the medication, as suddenly stopping blood pressure medicine can pose health risks.

Return any unused, affected product to your pharmacy to receive a refund.

Contact Torrent Pharma Inc. if you have further questions or need assistance with the return process at their distributor location: 1803 Whites Rd Ste 1, Kalamazoo, Michigan.

For additional information or to report a problem, 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, 100 mg (30, 90, or 1000-count)

Model:

NDC: 13668-115-30

NDC: 13668-115-90

NDC: 13668-115-10

Lot Numbers:

BO31C016 (Exp 04/2019)

4DK3C004 (Exp 04/2019)

4DK3C005 (Exp 04/2019)

4DU3C040 (Exp 10/2019)

4DU3E049 (Exp 05/2021)

4DU3E050 (Exp 05/2021)

Date Ranges: 04/2019, 10/2019, 05/2021

Product: LOSARTAN POTASSIUM TABLETS, USP, 50 mg (30, 90, or 1000-count)

Model:

NDC: 13668-409-30

NDC: 13668-409-90

NDC: 13668-409-10

Lot Numbers:

4L67C035 (Exp 10/2019)

4L67C036 (Exp 10/2019)

4O50C005 (Exp 11/2019)

Date Ranges: 10/2019, 11/2019

Product: LOSARTAN POTASSIUM TABLETS, USP, 25 mg (90-count)

Model:

NDC: 13668-113-90

Lot Numbers:

4O49C013 (Exp 09/2019)

Date Ranges: 09/2019

Product: LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg (90 or 1000-count)

Model:

NDC: 13668-117-90

NDC: 13668-117-10

Lot Numbers:

BX35C020 (Exp 05/2019)

BX35C049 (Exp 08/2019)

BX35C022 (Exp 05/2019)

BX35C023 (Exp 05/2019)

Date Ranges: 05/2019, 08/2019

Product: LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg (90 or 1000-count)

Model:

NDC: 13668-116-90

NDC: 13668-116-10

Lot Numbers:

BP02C008 (Exp 03/2019)

BEF7D006 (Exp 03/2020)

Date Ranges: 03/2019, 03/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81838

Status: Active

Manufacturer: Torrent Pharma Inc.

Sold By: pharmacies nationwide

Manufactured In: United States, India

Units Affected: 5 products (83,016 bottles; 65,832 bottles; 43,416 bottles; 18,852 bottles; 18,780 bottles)

Distributed To: Nationwide