Lupin Pharmaceuticals recalls 150/12.5 mg irbesartan and hydrochlorothiazide tablets with impurity N-nitrosoirbesartan detected in API. Affected lots expire through April 2022.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Lupin Pharmaceuticals is recalling certain irbesartan and hydrochlorothiazide tablets due to a detected impurity in the manufacturing process. This impurity could pose a health risk to users, though the specific health effects are not detailed in the recall notice.
The recall identifies an impurity called N-nitrosoirbesartan in the active pharmaceutical ingredient. While the exact health risk is not specified, impurities in medications can sometimes cause adverse reactions or health issues.
People who have the recalled tablets (150/12.5 mg) with specific lot numbers and expiration dates listed in the recall notice. Those taking blood pressure medication may be most at risk.
Check for the product name 'Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg' with lot numbers H804537 through H902530 and expiration dates up to April 2022. These tablets are prescription-only.
Identify the lot number and expiration date on the tablet packaging to determine if it is part of the recalled batch.
The recall is due to the detection of an impurity called 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 it is affected and contact your healthcare provider for advice.
The recall notice does not specify the health risks associated with the impurity.
We’ve drafted a message you can send Lupin to request your refund or repair — edit it as you like.
Subject: Recall D-0089-2022 — Lupin Lupin Hello, I own a Lupin that is covered by recall D-0089-2022 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.
