Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Irbesartan Bulk Active Pharmaceutical Ingredient. Recalled by Aurobindo Pharma Limited (Unit I) Due to CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen...
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 Aurobindo Pharma Limited (Unit I) directly.
Affected Products
Irbesartan Bulk Active Pharmaceutical Ingredient.
Quantity: 1724.8 kgs.
Why Was This Recalled?
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Where Was This Sold?
This product was distributed to 1 state: NY
About Aurobindo Pharma Limited (Unit I)
Aurobindo Pharma Limited (Unit I) has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report