Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Westminister 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
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.
Quantity: 5,989 HDPE
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