Medications & Supplements/Prescription Drugs

Rising Pharmaceuticals, Inc.: Valsartan Tablets Recalled for Trace Amounts of NDEA Impurity

Agency Publication Date: March 22, 2019

Summary

Rising Pharmaceuticals, Inc. is recalling 145,237 bottles of Valsartan tablets (40 mg, 80 mg, 160 mg, and 320 mg) because trace amounts of an unexpected impurity, N-nitrosodiethylamine (NDEA), were detected in the finished products. This chemical is classified as a probable human carcinogen. These prescription blood pressure medications were distributed nationwide to six major distributors and manufactured by Aurolife Pharma LLC.

Risk

The presence of N-nitrosodiethylamine (NDEA) is a concern because it is a known environmental contaminant and suspected carcinogen that may increase the risk of cancer with long-term exposure. No specific injuries or adverse events have been reported in this notice.

What You Should Do

Identify your medication by checking the NDC numbers and lot information on the bottle label. Affected products include: Valsartan 40 mg (NDC 52343-122-30), 80 mg (NDC 52343-123-90), 160 mg (NDC 52343-124-90), and 320 mg (NDC 52343-125-90).
Check your bottle for the following specific lot numbers and expiration dates: For 40 mg, look for 470170038A (Exp. 10/31/2019), 470180010A (Exp. 02/29/2019), or 470180012A (Exp. 03/31/2020).
For 80 mg, check for 471170019A (Exp. 10/31/2019), 471180006A (Exp. 03/31/2020), 471180007A (Exp. 03/31/2020), or 471180016A (Exp. 05/31/2020).
For 160 mg, check for 472180005B (Exp. 02/29/2020), 472180011A (Exp. 04/30/2020), or 472180012A (Exp. 04/30/2020).
For 320 mg, check for 473180007A (Exp. 03/31/2020), 473180008A (Exp. 03/31/2020), 473180011A (Exp. 04/30/2020), 473180020B1 (Exp. 07/31/2020), or 473170019B (Exp. 10/31/2019).
Do NOT stop taking your medication without first talking to your doctor or pharmacist. Abruptly stopping blood pressure medication can pose an immediate health risk; a healthcare professional can provide a safe alternative treatment.
Contact your pharmacist or Rising Pharmaceuticals to arrange for the return of any unused product and to discuss a refund.
Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

Full Refund

Contact healthcare provider and 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 40 mg USP (30 tablet bottles)

Model:

NDC 52343-122-30

Recall #: D-1052-2019

Lot Numbers:

470170038A (Exp. 10/31/2019)

470180010A (Exp. 02/29/2019)

470180012A (Exp. 03/31/2020)

Date Ranges: 10/31/2019, 02/29/2019, 03/31/2020

Product: Valsartan Tablets 80 mg USP (90 tablet bottles)

Model:

NDC 52343-123-90

Recall #: D-1053-2019

Lot Numbers:

471170019A (Exp. 10/31/2019)

471180006A (Exp. 03/31/2020)

471180007A (Exp. 03/31/2020)

471180016A (Exp. 05/31/2020)

Date Ranges: 10/31/2019, 03/31/2020, 05/31/2020

Product: Valsartan Tablets 160 mg USP (90 tablet bottles)

Model:

NDC 52343-124-90

Recall #: D-1054-2019

Lot Numbers:

472180005B (Exp. 02/29/2020)

472180011A (Exp. 04/30/2020)

472180012A (Exp. 04/30/2020)

Date Ranges: 02/29/2020, 04/30/2020

Product: Valsartan Tablets 320 mg USP (90 tablet bottles)

Model:

NDC 52343-125-90

Recall #: D-1055-2019

Lot Numbers:

473180007A (Exp. 03/31/2020)

473180008A (Exp. 03/31/2020)

473180011A (Exp. 04/30/2020)

473180020B1 (Exp. 07/31/2020)

473170019B (Exp. 10/31/2019)

Date Ranges: 03/31/2020, 04/30/2020, 07/31/2020, 10/31/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82337

Status: Active

Manufacturer: Rising Pharmaceuticals, Inc.

Sold By: Acetris Health, LLC; 6 major distributors

Manufactured In: United States

Units Affected: 4 products (30,530 bottles; 37,410 bottles; 35,281 bottles; 42,016 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

Identify your medication by checking the NDC numbers and lot information on the bottle label. Affected products include: Valsartan 40 mg (NDC 52343-122-30), 80 mg (NDC 52343-123-90), 160 mg (NDC 52343-124-90), and 320 mg (NDC 52343-125-90).

Check your bottle for the following specific lot numbers and expiration dates: For 40 mg, look for 470170038A (Exp. 10/31/2019), 470180010A (Exp. 02/29/2019), or 470180012A (Exp. 03/31/2020).

For 80 mg, check for 471170019A (Exp. 10/31/2019), 471180006A (Exp. 03/31/2020), 471180007A (Exp. 03/31/2020), or 471180016A (Exp. 05/31/2020).

For 160 mg, check for 472180005B (Exp. 02/29/2020), 472180011A (Exp. 04/30/2020), or 472180012A (Exp. 04/30/2020).

For 320 mg, check for 473180007A (Exp. 03/31/2020), 473180008A (Exp. 03/31/2020), 473180011A (Exp. 04/30/2020), 473180020B1 (Exp. 07/31/2020), or 473170019B (Exp. 10/31/2019).

Do NOT stop taking your medication without first talking to your doctor or pharmacist. Abruptly stopping blood pressure medication can pose an immediate health risk; a healthcare professional can provide a safe alternative treatment.

Contact your pharmacist or Rising Pharmaceuticals to arrange for the return of any unused product and to discuss a refund.

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

Affected Products

Product: Valsartan Tablets 40 mg USP (30 tablet bottles)

Model:

NDC 52343-122-30

Recall #: D-1052-2019

Lot Numbers:

470170038A (Exp. 10/31/2019)

470180010A (Exp. 02/29/2019)

470180012A (Exp. 03/31/2020)

Date Ranges: 10/31/2019, 02/29/2019, 03/31/2020

Product: Valsartan Tablets 80 mg USP (90 tablet bottles)

Model:

NDC 52343-123-90

Recall #: D-1053-2019

Lot Numbers:

471170019A (Exp. 10/31/2019)

471180006A (Exp. 03/31/2020)

471180007A (Exp. 03/31/2020)

471180016A (Exp. 05/31/2020)

Date Ranges: 10/31/2019, 03/31/2020, 05/31/2020

Product: Valsartan Tablets 160 mg USP (90 tablet bottles)

Model:

NDC 52343-124-90

Recall #: D-1054-2019

Lot Numbers:

472180005B (Exp. 02/29/2020)

472180011A (Exp. 04/30/2020)

472180012A (Exp. 04/30/2020)

Date Ranges: 02/29/2020, 04/30/2020

Product: Valsartan Tablets 320 mg USP (90 tablet bottles)

Model:

NDC 52343-125-90

Recall #: D-1055-2019

Lot Numbers:

473180007A (Exp. 03/31/2020)

473180008A (Exp. 03/31/2020)

473180011A (Exp. 04/30/2020)

473180020B1 (Exp. 07/31/2020)

473170019B (Exp. 10/31/2019)

Date Ranges: 03/31/2020, 04/30/2020, 07/31/2020, 10/31/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82337

Status: Active

Manufacturer: Rising Pharmaceuticals, Inc.

Sold By: Acetris Health, LLC; 6 major distributors

Manufactured In: United States

Units Affected: 4 products (30,530 bottles; 37,410 bottles; 35,281 bottles; 42,016 bottles)

Distributed To: Nationwide