Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Recalled by Prinston Pharmaceutical Inc Due to CGMP Deviations: FDA lab confirmed presence an impurity,...
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 Prinston Pharmaceutical Inc directly.
Affected Products
Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09
Quantity: 19800 bottles
Why Was This Recalled?
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Prinston Pharmaceutical Inc
Prinston Pharmaceutical Inc has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report