Lupin Pharmaceuticals recalls 25mg clomipramine capsules due to impurities detected in stability testing. This may cause serious health risks. Affected products have specific lot numbers and expiration dates.
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Lupin Pharmaceuticals is recalling clomipramine hydrochloride capsules (25mg, 100-count) because impurities were found during stability testing. This could pose a serious health risk to people taking the medication.
The capsules failed stability testing, showing impurities that could be harmful. This means the medication might not be safe for use as intended, potentially causing serious health issues.
People with a prescription for clomipramine hydrochloride capsules (25mg, 100-count) from Lupin Pharmaceuticals. Those who have the specific lot number M300442 are most at risk.
Check for the product name 'clomipramine hydrochloride capsules USP, 25 mg, 100-count bottle' with lot number M300442. The expiration date is June 30, 2025.
Look for the lot number M300442 on the packaging to confirm if your product is affected.
The recall record states that impurities were found during stability testing, so the product is not safe for use.
The recall record does not specify a remedy, so you should check with your healthcare provider for guidance.
Check for the lot number M300442 on the packaging. The product expires June 30, 2025.
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0377-2025 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-0377-2025 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.
