Medications & Supplements/Prescription Drugs

Northwind Pharmaceuticals LLC: Valsartan Medications Recalled Due to Potential Carcinogen Impurity

Agency Publication Date: August 15, 2018

Summary

Northwind Pharmaceuticals LLC has recalled approximately 127 bottles of various Valsartan and Valsartan HCTZ blood pressure medications. This recall was initiated because a carcinogenic impurity was detected in the active pharmaceutical ingredient (API) used to manufacture these drugs. These products were repackaged by Northwind Pharmaceuticals and distributed specifically in Indiana.

Risk

The medications may contain an impurity that is classified as a probable human carcinogen, which could potentially increase the risk of cancer with long-term exposure. No specific injuries or adverse health events have been reported to date for these specific lots.

What You Should Do

Check your prescription bottle label to see if your medication is one of the affected products: Valsartan (80mg, 160mg, 320mg) or Valsartan HCTZ (160/12.5mg) repackaged by Northwind Pharmaceuticals.
Verify the Lot Number and Expiration Date on your bottle. Affected lots for Valsartan 160mg are UT48320002 (Exp 07/31/2018) and UT48320003 (Exp 05/31/2019).
Check for Valsartan HCTZ 160/12.5mg lot UTB23790003 (Exp 02/28/2019); Valsartan 80mg lot UT48310002 (Exp 10/31/2018); or Valsartan 320mg lot UT48100001 (Exp 9/30/2019).
Contact your healthcare provider or pharmacist immediately for guidance before you stop taking your medication, as stopping blood pressure medicine abruptly can be dangerous.
Return any unused product from the affected lots to your pharmacy for a refund and contact Northwind Pharmaceuticals for further instructions.
For additional questions, 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

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

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

Affected Products

Product: Valsartan, 160 mg, 30 tablets per bottle

Model:

NDC: 51655-460-52

Lot Numbers:

UT48320002 (Exp 07/31/2018)

UT48320003 (Exp 05/31/2019)

Date Ranges: 07/31/2018, 05/31/2019

Product: Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle

Model:

NDC: 51655-950-52

Lot Numbers:

UTB23790003 (Exp 02/28/2019)

Date Ranges: 02/28/2019

Product: Valsartan, 80mg, 30 tablets per bottle

Model:

NDC: 51655-0652-52

Lot Numbers:

UT48310002 (Exp 10/31/2018)

Date Ranges: 10/31/2018

Product: Valsartan, 320mg, 30 tablets per bottle

Model:

NDC: 51655-0654-52

Lot Numbers:

UT48100001 (Exp 9/30/2019)

Date Ranges: 9/30/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80703

Status: Resolved

Manufacturer: Northwind Pharmaceuticals LLC

Sold By: Northwind Pharmaceuticals

Manufactured In: United States

Units Affected: 4 products (68 bottles; 43 bottles; 2 bottles; 14 bottles)

Distributed To: Indiana

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 label to see if your medication is one of the affected products: Valsartan (80mg, 160mg, 320mg) or Valsartan HCTZ (160/12.5mg) repackaged by Northwind Pharmaceuticals.

Verify the Lot Number and Expiration Date on your bottle. Affected lots for Valsartan 160mg are UT48320002 (Exp 07/31/2018) and UT48320003 (Exp 05/31/2019).

Check for Valsartan HCTZ 160/12.5mg lot UTB23790003 (Exp 02/28/2019); Valsartan 80mg lot UT48310002 (Exp 10/31/2018); or Valsartan 320mg lot UT48100001 (Exp 9/30/2019).

Contact your healthcare provider or pharmacist immediately for guidance before you stop taking your medication, as stopping blood pressure medicine abruptly can be dangerous.

Return any unused product from the affected lots to your pharmacy for a refund and contact Northwind Pharmaceuticals for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Valsartan, 160 mg, 30 tablets per bottle

Model:

NDC: 51655-460-52

Lot Numbers:

UT48320002 (Exp 07/31/2018)

UT48320003 (Exp 05/31/2019)

Date Ranges: 07/31/2018, 05/31/2019

Product: Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle

Model:

NDC: 51655-950-52

Lot Numbers:

UTB23790003 (Exp 02/28/2019)

Date Ranges: 02/28/2019

Product: Valsartan, 80mg, 30 tablets per bottle

Model:

NDC: 51655-0652-52

Lot Numbers:

UT48310002 (Exp 10/31/2018)

Date Ranges: 10/31/2018

Product: Valsartan, 320mg, 30 tablets per bottle

Model:

NDC: 51655-0654-52

Lot Numbers:

UT48100001 (Exp 9/30/2019)

Date Ranges: 9/30/2019