Lupin Pharmaceuticals recalls 150mg Irbesartan Tablets (NDC 68180-411-06/09) due to impurity N-nitrosoirbesartan detected in the active ingredient. Rx only products with specific lot numbers and expiration dates are affected.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Lupin Pharmaceuticals is recalling 150mg Irbesartan Tablets (30-count and 90-count bottles) that were manufactured with a harmful impurity. This recall affects prescription-only products with specific lot numbers and expiration dates. The impurity could pose a health risk if taken as directed.
The recall is due to the detection of an impurity called N-nitrosoirbesartan in the active ingredient (API) of the medication. This impurity may pose a health risk if the medication is taken as directed, though the exact risk level is not specified in the recall notice.
Prescription patients who have the specific lot numbers and expiration dates listed for the 150mg Irbesartan Tablets. Those with the affected products are at risk due to the impurity detected in the active ingredient.
Check the product label for the brand name Lupin Pharmaceuticals, the product name Irbesartan Tablets USP 150 mg, and the specific lot numbers and expiration dates listed in the recall notice. The affected products are prescription-only and come in 30-count and 90-count bottles with the NDC codes 68180-411-06 and 68180-411-09.
Look for the specific lot numbers and expiration dates listed in the recall notice on the product label.
The recall is due to the detection of an impurity called N-nitrosoirbesartan in the active ingredient (API) of the medication.
The recall notice does not specify a remedy, so you should check the product label for the specific lot numbers and expiration dates listed in the recall notice.
The recall notice does not specify the health risk level, but the presence of an impurity may pose a health risk if taken as directed.
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0087-2022 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-0087-2022 from Lupin Pharmaceuticals. 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.
