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.
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Contact the company
📍Recalling firmLupin Pharmaceuticals Inc.5801 Pelican Bay Blvd, Suite 500 · Naples, FL 34108-2755
“Lupin Clomipramine Capsules Recall: Impurities Risk Serious Harm.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32153-lupin-clomipramine-capsules-recall-impurities-risk-serious-harm. Based on FDA recall #D-0377-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0377-2025%22&limit=1).
Lupin Pharmaceuticals Inc. recalled clomipramine hydrochloride Capsules USP, 25 mg, 100-count bottles nationwide due to failed impurity specifications, the FDA said on April 10, 2025.
The recall addresses out-of-specification results observed in degradation product tests during an 18-month long-term stability study. The FDA classified the recall as Class II.
Context
GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since January 31, 2013. Other recent recalls of similar products include Lupin Clobetasol Cream Recall (August 3, 2026), Lupin Glucagon Emergency Kit Recall (June 23, 2026), and Lupin prednisolone acetate ophthalmic suspension recall (June 4, 2026). Other recent recalls of similar products include Zydus Clomipramine Capsules Recall (October 22, 2025), Hikma Ramipril Capsules 10mg Recall (August 24, 2026), and Asclemed Duloxetine Capsules Recall (May 14, 2026).
How to tell if you have this one
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.
Brand
Lupin Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number M300442 on the packaging to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #D-0377-2025 (April 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0377-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.