Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GSMS Irbesartan Tablets Recalled by Sciegen Pharmaceuticals Inc Due to CGMP Deviations: FDA laboratory testing confirmed presence of...
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 Sciegen Pharmaceuticals Inc directly.
Affected Products
GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
Quantity: 18,760 HDPE bottles
Why Was This Recalled?
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sciegen Pharmaceuticals Inc
Sciegen Pharmaceuticals Inc has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report