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
Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA.
Brand
Sciegen Pharmaceuticals Inc
Lot Codes / Batch Numbers
69367-121-01 Irbesartan 300mg Tablets, 30 count bottle B162008A Sep-19 C162002A Feb-20 69367-121-03 Irbesartan 300mg Tablets, 90 count bottle B162008B Sep-19 C162002B Feb-20
Products Sold
69367-121-01 Irbesartan 300mg Tablets, 30 count bottle B162008A Sep-19 C162002A Feb-20 69367-121-03 Irbesartan 300mg Tablets, 90 count bottle B162008B Sep-19 C162002B Feb-20
Sciegen Pharmaceuticals Inc is recalling Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-c 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