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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 #: M300442, Exp Date: 6/30/2025
Where it was soldUSA nationwide
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 18-month long term stability study.

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 Limited, Nagpur, 441 108 INDIA foreign manufacturer
Brand nameCLOMIPRAMINE HYDROCHLORIDE
Generic nameCLOMIPRAMINE HYDROCHLORIDE CAPSULES
Active ingredient(s)CLOMIPRAMINE HYDROCHLORIDE
Distributed by / forLupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States
NDC68180-492-01
Show the full FDA record
Full product labelclomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01
Recalling firmLupin Pharmaceuticals Inc.
DistributionUSA nationwide
Quantity2724 bottles
Recall initiated2025-04-10
Report date2025-04-30
Recall completed2026-01-05
Recall numberD-0377-2025
ClassificationClass II
FDA statusTerminated
Origin on fileNaples FL United States

Related

Recent drug recallsCheck another medication

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.