Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Westminster Irbesartan Tablets Recalled by Westminster Pharmaceuticals Llc Due to CGMP Deviations: FDA laboratory testing confirmed traces 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 Westminster Pharmaceuticals Llc directly.
Affected Products
Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03
Quantity: 3976 bottles
Why Was This Recalled?
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Westminster Pharmaceuticals Llc
Westminster Pharmaceuticals Llc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report