Irbesartan Tablets 300mg (Sciegen) – NDEA Impurity Detected (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
GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
Brand
Sciegen Pharmaceuticals Inc
Lot Codes / Batch Numbers
60429-642-30 Irbesartan 300mg Tablets
Products Sold
60429-642-30 Irbesartan 300mg Tablets, 30 Count Bottle GS019036 Sep-19 GS019073 Sep-19 GS021472 Nov-19 GS021530 Nov-19 GS022234 Feb-20 60429-642-90 Irbesartan 300mg Tablets, 90 Count Bottle B162009 Sep-19 B162010 Sep-19 B162011 Sep-19 B162012 Nov-19 B162013 Nov-19 B162014 Nov-19 B162015 Nov-19 C162001 Feb-20
Sciegen Pharmaceuticals Inc is recalling GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (ND due to CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in 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: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in 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