Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IRBESARTAN Tablets Recalled by Golden State Medical Supply 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 Golden State Medical Supply Inc. directly.
Affected Products
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: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
Quantity: 15,917 bottles
Why Was This Recalled?
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Where Was This Sold?
Product was distributed throughout the United States.
About Golden State Medical Supply Inc.
Golden State Medical Supply Inc. has 50 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report