Medications & Supplements/Prescription Drugs

RemedyRepack Inc.: Valsartan/HCTZ Tablets Recalled Due to Carcinogen Impurity

Agency Publication Date: July 31, 2018

Summary

RemedyRepack Inc. is recalling 7 bottles of Valsartan/HCTZ (valsartan and hydrochlorothiazide) 160 mg/12.5 mg and 320 mg/12.5 mg tablets. This recall was initiated because a carcinogen impurity was detected in the active pharmaceutical ingredient (API) used to manufacture the medication. These products were distributed to three medical facilities in Florida. Consumers should contact their doctor or pharmacist immediately, as it can be dangerous to stop taking blood pressure medication without a replacement.

Risk

The medication contains an impurity that is classified as a possible human carcinogen, which could increase the risk of cancer with long-term exposure.

What You Should Do

Check your medication packaging to see if you have Valsartan/HCTZ 160 mg/12.5 mg (90-count bottle) with lot number B0318652-070617 and expiration date 07/18.
Check your medication packaging to see if you have Valsartan/HCTZ 320 mg/12.5 mg (90-count bottle) with lot number B0383153-122917 and expiration date 12/18.
Contact your healthcare provider or pharmacist immediately for guidance and to discuss an alternative treatment before you stop taking the medication.
Return any unused product to the pharmacy or medical facility where you received it for a refund.
Contact RemedyRepack Inc. at their Indiana, PA location for further instructions regarding the return of the affected products.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse effects.

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/HCTZ 160 mg/12.5 mg tablet (90-count bottle)

Model:

D-1020-2018

Lot Numbers:

B0318652-070617 (Exp. 07/18)

Date Ranges: Expiration: 07/18

Product: Valsartan/HCTZ 320 mg/12.5 mg tablet (90-count bottle)

Model:

D-1021-2018

Lot Numbers:

B0383153-122917 (Exp. 12/18)

Date Ranges: Expiration: 12/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80646

Status: Resolved

Manufacturer: RemedyRepack Inc.

Sold By: medical facilities

Manufactured In: United States

Units Affected: 2 products (4 HDPE 90-count bottles (360 tablets); 3 HDPE 90-count bottles (270 tablets))

Distributed To: Florida

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 packaging to see if you have Valsartan/HCTZ 160 mg/12.5 mg (90-count bottle) with lot number B0318652-070617 and expiration date 07/18.

Check your medication packaging to see if you have Valsartan/HCTZ 320 mg/12.5 mg (90-count bottle) with lot number B0383153-122917 and expiration date 12/18.

Contact your healthcare provider or pharmacist immediately for guidance and to discuss an alternative treatment before you stop taking the medication.

Return any unused product to the pharmacy or medical facility where you received it for a refund.

Contact RemedyRepack Inc. at their Indiana, PA location for further instructions regarding the return of the affected products.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse effects.

Affected Products

Product: Valsartan/HCTZ 160 mg/12.5 mg tablet (90-count bottle)

Model:

D-1020-2018

Lot Numbers:

B0318652-070617 (Exp. 07/18)

Date Ranges: Expiration: 07/18

Product: Valsartan/HCTZ 320 mg/12.5 mg tablet (90-count bottle)

Model:

D-1021-2018

Lot Numbers:

B0383153-122917 (Exp. 12/18)

Date Ranges: Expiration: 12/18