Valsartan Hydrochlorothiazide 320mg (Avkare) – Carcinogen Impurity (2018)
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
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90
Brand
Avkare Incorporated
Lot Codes / Batch Numbers
Lots: 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
Products Sold
Lots: 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
Avkare Incorporated is recalling AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactu due to CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.. 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: Carcinogen impurity detected in API used to manufacture drug product.
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