Lupin Pharmaceuticals recalls 25mg clomipramine capsules due to potential impurities from degradation. Affected lots may pose safety risks. Check NDC# 68180-492-01 and lot numbers for details.
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Take action
Contact the company
📍Recalling firmLupin Pharmaceuticals Inc.5801 Pelican Bay Blvd, Suite 500 · Naples, FL 34108-2755
“Lupin Clomipramine Capsules Recall: Failed Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32010-lupin-clomipramine-capsules-recall-failed-impurities-risk. Based on FDA recall #D-0537-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0537-2025%22&limit=1).
The FDA announced on June 27, 2025, that Lupin Pharmaceuticals Inc. is recalling clomipramine hydrochloride capsules due to failed impurity specifications. The agency said the recall involves 2,724 bottles distributed nationwide.
The FDA said the recall is due to an out-of-specification result observed in a degradation product test during retention sample testing at expiry. The agency classified the recall as Class II.
Context
GovInfoNow's records show Lupin Pharmaceuticals Inc. has had 90 other recalls on record since Jan. 31, 2013. Other recent recalls of similar products include a Lupin Clobetasol Cream recall (Aug. 3, 2026) and a Lupin Glucagon Emergency Kit recall (June 23, 2026). Similar recent recalls also include a Lupin prednisolone acetate ophthalmic suspension recall (June 4, 2026), a Zydus Clomipramine Capsules recall (Oct. 22, 2025), a Hikma Ramipril Capsules 10mg recall (Aug. 24, 2026), and a SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution recall (Nov. 26, 2025).
How to tell if you have this one
Check for the NDC code 68180-492-01 and lot number M300464 on the bottle. The capsules are 25mg, 100-count bottles sold by Lupin Pharmaceuticals in Naples, Florida.
Brand
Lupin Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for NDC# 68180-492-01 and lot number M300464 on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “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 6 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-0537-2025 (June 27, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0537-2025 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.