Lupin Pharmaceuticals recalls 5mg Ramipril capsules due to active pharmaceutical ingredient sourced from an unapproved vendor. Affected lots have specific NDC numbers and expiration dates.
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Lupin Pharmaceuticals is recalling 5mg Ramipril capsules that were made using an unapproved supplier for the active ingredient. This could lead to inconsistent drug quality or safety issues if taken without proper quality control.
The active pharmaceutical ingredient was sourced from an unapproved vendor, which may result in inconsistent drug quality. This could affect the medication's effectiveness or safety, especially for individuals who need precise dosing.
People who have purchased or received these specific lots of Ramipril capsules from pharmacies or hospitals. Those with high blood pressure who rely on this medication are most at risk.
Check the product label for the NDC numbers: 68180-590-09 (90 count), 68180-590-01 (100 count), or 68180-590-02 (500 count). Also look for expiration dates matching the listed lots.
Look for the NDC numbers and expiration dates listed in the recall notice to confirm if your product is affected.
The active pharmaceutical ingredient was sourced from an unapproved vendor, which may result in inconsistent drug quality.
The recall notice does not specify a remedy, so check the product label for NDC numbers and expiration dates to determine if your product is affected.
Yes, affected lots have specific expiration dates: 30-Sep-25 or 31-Dec-25, depending on the lot number.
We’ve drafted a message you can send Lupin to request your refund or repair — edit it as you like.
Subject: Recall D-0053-2025 — Lupin Lupin Hello, I own a Lupin that is covered by recall D-0053-2025 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.