Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Irbesartan Tablets USP Recalled by Lupin Pharmaceuticals Inc. Due to CGMP Deviations: impurity N-nitrosoirbesartan detected in API
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 Lupin Pharmaceuticals Inc. directly.
Affected Products
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
Quantity: 134,016 bottles
Why Was This Recalled?
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Lupin Pharmaceuticals Inc.
Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report