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Class II · ModerateRecall completed

Clomipramine Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # M300464, exp. date June, 2025
Where it was soldNationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Pharmaceuticals, Inc.
Brand nameCLOMIPRAMINE HYDROCHLORIDE
Generic nameCLOMIPRAMINE HYDROCHLORIDE CAPSULES
Active ingredient(s)CLOMIPRAMINE HYDROCHLORIDE
Distributed by / forLupin Pharmaceuticals Inc.
NDC68180-492-01
Show the full FDA record
Full product labelclomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Recalling firmLupin Pharmaceuticals Inc.
DistributionNationwide.
Quantity2,724 bottles
Recall initiated2025-06-27
Report date2025-07-30
Recall completed2026-01-05
Recall numberD-0537-2025
ClassificationClass II
FDA statusTerminated
Origin on fileNaples FL United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.