Medications & Supplements/Prescription Drugs

Avkare Incorporated: Valsartan and Hydrochlorothiazide Tablets Recalled for Carcinogen Impurity

Agency Publication Date: September 6, 2018

Summary

Avkare Incorporated is recalling 88,718 bottles of various strengths of Valsartan and Hydrochlorothiazide combination tablets, used to treat high blood pressure. The recall was initiated because a cancer-causing impurity was detected in the active pharmaceutical ingredient (API) used to make the medication. This affects 90-count prescription bottles sold nationwide between 2017 and 2018.

Risk

The drug contains a carcinogen impurity that exceeds safety standards, which may increase the risk of cancer in patients who consume the medication over a long period. No specific injuries or adverse events have been reported to date, but the deviation from manufacturing safety standards poses a medium-term health risk.

What You Should Do

Check your prescription bottle for 'AvKARE Valsartan and Hydrochlorothiazide' in strengths of 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, or 320/25 mg.
Verify if your bottle matches the affected lot numbers and expiration dates: for 80/12.5 mg (Lots 17349, 18395, 19221, 20029, 20158, 20843, 21411), 160/12.5 mg and 160/25 mg (Lots 17325, 17856, 18396, 18702, 19020, 19222, 20030, 20381), 320/12.5 mg (Lots 17780, 18029, 18398, 18723, 19017, 19224, 20032, 20289, 21076, 21382), or 320/25 mg (Lots 17308, 18158, 18539, 19021, 19225, 20033, 20290, 20565, 21369).
Do not stop taking your medication without first consulting your healthcare provider or pharmacist, as the risk of suddenly stopping blood pressure medication may be greater than the risk of the impurity.
Contact your healthcare provider or pharmacist for guidance on an alternative treatment and return any unused product to the pharmacy for a refund.
Contact AvKARE, Inc. at their Pulaski, Tennessee headquarters or through your dispensing pharmacy 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

Healthcare provider consultation and pharmacy return

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

Affected Products

Product: AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets (90-count bottle)

Model:

NDC 42291-884-90

Recall #: D-1173-2018

Lot Numbers:

17349 (Exp. 08/2018)

18395 (Exp. 08/2018)

19221 (Exp. 06/2019)

20029 (Exp. 06/2019)

20158 (Exp. 07/2019)

20843 (Exp. 07/2019)

21411 (Exp. 09/2019)

Date Ranges: 08/2018, 06/2019, 07/2019, 09/2019

Product: AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets (90-count bottle)

Model:

NDC 42291-885-90

Recall #: D-1174-2018

Lot Numbers:

17325 (Exp. 09/2018)

17856 (Exp. 09/2018)

18396 (Exp. 09/2018)

18702 (Exp. 02/2019)

19020 (Exp. 02/2019)

19222 (Exp. 02/2019)

20030 (Exp. 04/2019)

20381 (Exp. 04/2019)

Date Ranges: 09/2018, 02/2019, 04/2019

Product: AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets (90-count bottle)

Model:

NDC 42291-887-90

Recall #: D-1175-2018

Lot Numbers:

17325 (Exp. 09/2018)

17856 (Exp. 09/2018)

18396 (Exp. 09/2018)

18702 (Exp. 02/2019)

19020 (Exp. 02/2019)

19222 (Exp. 02/2019)

20030 (Exp. 04/2019)

20381 (Exp. 04/2019)

Date Ranges: 09/2018, 02/2019, 04/2019

Product: AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets (90-count bottle)

Model:

NDC 42291-886-90

Recall #: D-1176-2018

Lot Numbers:

17780 (Exp. 09/2018)

18029 (Exp. 09/2018)

18398 (Exp. 09/2018)

18723 (Exp. 09/2018)

19017 (Exp. 02/2019)

19224 (Exp. 02/2019)

20032 (Exp. 08/2019)

20289 (Exp. 08/2019)

21076 (Exp. 08/2019)

21382 (Exp. 08/2019)

Date Ranges: 09/2018, 02/2019, 08/2019

Product: AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets (90-count bottle)

Model:

NDC 42291-888-90

Recall #: D-1177-2018

Lot Numbers:

17308 (Exp. 09/2018)

18158 (Exp. 09/2018)

18539 (Exp. 01/2019)

19021 (Exp. 01/2019)

19225 (Exp. 01/2019)

20033 (Exp. 06/2019)

20290 (Exp. 06/2019)

20565 (Exp. 06/2019)

21369 (Exp. 10/2019)

Date Ranges: 09/2018, 01/2019, 06/2019, 10/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80940

Status: Resolved

Manufacturer: Avkare Incorporated

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 5 products (12240 bottles; 24796 bottles; 19109 bottles; 12950 bottles; 19623 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

Risk

What You Should Do

Check your prescription bottle for 'AvKARE Valsartan and Hydrochlorothiazide' in strengths of 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, or 320/25 mg.

Verify if your bottle matches the affected lot numbers and expiration dates: for 80/12.5 mg (Lots 17349, 18395, 19221, 20029, 20158, 20843, 21411), 160/12.5 mg and 160/25 mg (Lots 17325, 17856, 18396, 18702, 19020, 19222, 20030, 20381), 320/12.5 mg (Lots 17780, 18029, 18398, 18723, 19017, 19224, 20032, 20289, 21076, 21382), or 320/25 mg (Lots 17308, 18158, 18539, 19021, 19225, 20033, 20290, 20565, 21369).

Do not stop taking your medication without first consulting your healthcare provider or pharmacist, as the risk of suddenly stopping blood pressure medication may be greater than the risk of the impurity.

Contact your healthcare provider or pharmacist for guidance on an alternative treatment and return any unused product to the pharmacy for a refund.

Contact AvKARE, Inc. at their Pulaski, Tennessee headquarters or through your dispensing pharmacy 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: AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets (90-count bottle)

Model:

NDC 42291-884-90

Recall #: D-1173-2018

Lot Numbers:

17349 (Exp. 08/2018)

18395 (Exp. 08/2018)

19221 (Exp. 06/2019)

20029 (Exp. 06/2019)

20158 (Exp. 07/2019)

20843 (Exp. 07/2019)

21411 (Exp. 09/2019)

Date Ranges: 08/2018, 06/2019, 07/2019, 09/2019

Product: AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets (90-count bottle)

Model:

NDC 42291-885-90

Recall #: D-1174-2018

Lot Numbers:

17325 (Exp. 09/2018)

17856 (Exp. 09/2018)

18396 (Exp. 09/2018)

18702 (Exp. 02/2019)

19020 (Exp. 02/2019)

19222 (Exp. 02/2019)

20030 (Exp. 04/2019)

20381 (Exp. 04/2019)

Date Ranges: 09/2018, 02/2019, 04/2019

Product: AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets (90-count bottle)

Model:

NDC 42291-887-90

Recall #: D-1175-2018

Lot Numbers:

17325 (Exp. 09/2018)

17856 (Exp. 09/2018)

18396 (Exp. 09/2018)

18702 (Exp. 02/2019)

19020 (Exp. 02/2019)

19222 (Exp. 02/2019)

20030 (Exp. 04/2019)

20381 (Exp. 04/2019)

Date Ranges: 09/2018, 02/2019, 04/2019

Product: AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets (90-count bottle)

Model:

NDC 42291-886-90

Recall #: D-1176-2018

Lot Numbers:

17780 (Exp. 09/2018)

18029 (Exp. 09/2018)

18398 (Exp. 09/2018)

18723 (Exp. 09/2018)

19017 (Exp. 02/2019)

19224 (Exp. 02/2019)

20032 (Exp. 08/2019)

20289 (Exp. 08/2019)

21076 (Exp. 08/2019)

21382 (Exp. 08/2019)

Date Ranges: 09/2018, 02/2019, 08/2019

Product: AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets (90-count bottle)

Model:

NDC 42291-888-90

Recall #: D-1177-2018

Lot Numbers:

17308 (Exp. 09/2018)

18158 (Exp. 09/2018)

18539 (Exp. 01/2019)

19021 (Exp. 01/2019)

19225 (Exp. 01/2019)

20033 (Exp. 06/2019)

20290 (Exp. 06/2019)

20565 (Exp. 06/2019)

21369 (Exp. 10/2019)

Date Ranges: 09/2018, 01/2019, 06/2019, 10/2019