Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Valsartan Tablets 80 mg USP Recalled by Rising Pharmaceuticals, Inc. Due to CGMP Deviations; Detection of a trace amount of...

Date: March 7, 2019
Company: Rising Pharmaceuticals, Inc.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Rising Pharmaceuticals, Inc. directly.

Affected Products

Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-123-90

Quantity: 37,410 bottles

Why Was This Recalled?

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Where Was This Sold?

Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.

About Rising Pharmaceuticals, Inc.

Rising Pharmaceuticals, Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report