Lupin Pharmaceuticals recalls specific lots of Irbesartan and Hydrochlorothiazide tablets due to detected impurity N-nitrosoirbesartan in the manufacturing process.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Lupin Pharmaceuticals is recalling certain lots of Irbesartan and Hydrochlorothiazide tablets because they contain an impurity called N-nitrosoirbesartan. This impurity could pose a health risk, though the exact risk level isn't specified in the recall notice.
The recall is due to the detection of an impurity called N-nitrosoirbesartan in the active pharmaceutical ingredient during manufacturing. This impurity could potentially cause health issues, but the specific health risks are not detailed in the recall notice.
People who have the recalled lots of Irbesartan and Hydrochlorothiazide tablets (30-count or 90-count) from Lupin Pharmaceuticals. Those with prescription for these medications are most at risk.
Check for the product name 'Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg' with the specific lot numbers listed in the recall notice. These tablets are prescription-only and come in 30-count or 90-count bottles.
Look for the product name and lot numbers listed in the recall notice to confirm if your tablets are affected.
Lupin Pharmaceuticals detected the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient during manufacturing.
The recall notice does not specify a remedy, so you should check the product details to see if your tablets are affected.
The recall notice does not specify the health risks associated with the impurity N-nitrosoirbesartan.
We’ve drafted a message you can send Lupin to request your refund or repair — edit it as you like.
Subject: Recall D-0090-2022 — Lupin Lupin Hello, I own a Lupin that is covered by recall D-0090-2022 from Lupin. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
