Medications & Supplements/Prescription Drugs

AVKARE Inc.: Valsartan Tablets Recalled Due to Potential Carcinogen Impurity

Agency Publication Date: August 28, 2018

Summary

AVKARE Inc. is recalling 9,818 cartons (approximately 460,980 tablets) of Valsartan Tablets, which are used to treat high blood pressure and heart failure. The recall was initiated because a carcinogen impurity (NDMA) was detected in the active pharmaceutical ingredient used to manufacture these specific lots. Consumers using this prescription medication should not stop taking it without first consulting a healthcare provider, as the risk of stopping the medication suddenly may be higher than the risk of the impurity.

Risk

The tablets may contain N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. Long-term exposure to NDMA at levels above acceptable limits is associated with an increased risk of developing cancer.

What You Should Do

Check your prescription bottle and outer packaging for the following NDC numbers: 50268-783-15 (40 mg), 50268-784-15 (80 mg), 50268-785-15 (160 mg), or 50268-786-13 (320 mg).
Verify if your medication belongs to the affected lots: For 40 mg, check for lots 18491, 19531, 20168, 20671, 21049, or 21635; for 80 mg, check for 18492 or 20169; for 160 mg, check for 17717, 18493, or 19761; and for 320 mg, check for 17718, 18700, 19133, or 19532.
If you identify your product as part of this recall, contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking the medication.
Return any unused portions of the affected medication to your pharmacy for a refund and contact AVKARE Inc. for further instructions regarding the return process.
Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Full Refund

Contact healthcare provider or pharmacist; return product for 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 Tablets, USP 40 mg Rx Only (50 Tablets Unit Dose)

Model:

NDC 50268-783-15

Lot Numbers:

18491 (Exp. 10/2018)

19531 (Exp. 04/2019)

20168 (Exp. 05/2019)

20671 (Exp. 08/2019)

21049 (Exp. 10/2019)

21635 (Exp. 10/2019)

Date Ranges: October 2018, April 2019, May 2019, August 2019, October 2019

Product: Valsartan Tablets, USP 80 mg Rx Only (50 Tablets Unit Dose)

Model:

NDC 50268-784-15

Lot Numbers:

18492 (Exp. 11/2018)

20169 (Exp. 05/2019)

Date Ranges: November 2018, May 2019

Product: Valsartan Tablets, USP 160 mg Rx Only (50 Tablets Unit Dose)

Model:

NDC 50268-785-15

Lot Numbers:

17717 (Exp. 07/2018)

18493 (Exp. 01/2019)

19761 (Exp. 04/2019)

Date Ranges: July 2018, January 2019, April 2019

Product: Valsartan Tablets, USP 320 mg Rx Only (30 Tablets Unit Dose)

Model:

NDC 50268-786-13

Lot Numbers:

17718 (Exp. 07/2018)

18700 (Exp. 01/2019)

19133 (Exp. 02/2019)

19532 (Exp. 04/2019)

Date Ranges: July 2018, January 2019, February 2019, April 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80828

Status: Resolved

Manufacturer: AVKARE Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 4 products (6776 cartons (338,800 tablets); 728 cartons (36,400 tablets); 818 cartons (40,900 tablets); 1496 cartons (44,880 tablets))

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 prescription bottle and outer packaging for the following NDC numbers: 50268-783-15 (40 mg), 50268-784-15 (80 mg), 50268-785-15 (160 mg), or 50268-786-13 (320 mg).

Verify if your medication belongs to the affected lots: For 40 mg, check for lots 18491, 19531, 20168, 20671, 21049, or 21635; for 80 mg, check for 18492 or 20169; for 160 mg, check for 17717, 18493, or 19761; and for 320 mg, check for 17718, 18700, 19133, or 19532.

If you identify your product as part of this recall, contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking the medication.

Return any unused portions of the affected medication to your pharmacy for a refund and contact AVKARE Inc. for further instructions regarding the return process.

Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Affected Products

Product: Valsartan Tablets, USP 40 mg Rx Only (50 Tablets Unit Dose)

Model:

NDC 50268-783-15

Lot Numbers:

18491 (Exp. 10/2018)

19531 (Exp. 04/2019)

20168 (Exp. 05/2019)

20671 (Exp. 08/2019)

21049 (Exp. 10/2019)

21635 (Exp. 10/2019)

Date Ranges: October 2018, April 2019, May 2019, August 2019, October 2019

Product: Valsartan Tablets, USP 80 mg Rx Only (50 Tablets Unit Dose)

Model:

NDC 50268-784-15

Lot Numbers:

18492 (Exp. 11/2018)

20169 (Exp. 05/2019)

Date Ranges: November 2018, May 2019

Product: Valsartan Tablets, USP 160 mg Rx Only (50 Tablets Unit Dose)

Model:

NDC 50268-785-15

Lot Numbers:

17717 (Exp. 07/2018)

18493 (Exp. 01/2019)

19761 (Exp. 04/2019)

Date Ranges: July 2018, January 2019, April 2019

Product: Valsartan Tablets, USP 320 mg Rx Only (30 Tablets Unit Dose)

Model:

NDC 50268-786-13

Lot Numbers:

17718 (Exp. 07/2018)

18700 (Exp. 01/2019)

19133 (Exp. 02/2019)

19532 (Exp. 04/2019)

Date Ranges: July 2018, January 2019, February 2019, April 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80828

Status: Resolved

Manufacturer: AVKARE Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 4 products (6776 cartons (338,800 tablets); 728 cartons (36,400 tablets); 818 cartons (40,900 tablets); 1496 cartons (44,880 tablets))

Distributed To: Nationwide