Valsartan 320mg Tablets (Rising) – CGMP Impurity (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-125-90
Brand
Rising Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
473180007A, exp. date 03/31/2020 473180008A, exp. date 03/31/2020 473180011A, exp. date 04/30/2020 473180020B1, exp. date 07/31/2020 473170019B, exp. date 10/31/2019
Products Sold
473180007A, exp. date 03/31/2020 473180008A, exp. date 03/31/2020 473180011A, exp. date 04/30/2020 473180020B1, exp. date 07/31/2020 473170019B, exp. date 10/31/2019
Rising Pharmaceuticals, Inc. is recalling Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, due to CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026