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Class II · ModerateActive recall

Desipramine Hydrochloride

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

Does this affect you?
Check your lot numberLot#: 18035739, Exp. Date: 11/30/2025
Where it was soldU.S. 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

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

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 byUSV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816 foreign manufacturer
Brand nameDESIPRAMINE HYDROCHLORIDE
Generic nameDESIPRAMINE HYDROCHLORIDE
Active ingredient(s)DESIPRAMINE HYDROCHLORIDE
Distributed by / forAvet Pharmaceuticals Inc., East Brunswick, NJ 08816
NDC23155-583-25
Show the full FDA record
Full product labelDesipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Recalling firmHeritage Pharmaceuticals Inc
DistributionU.S. Nationwide.
Quantity3,750 bottles.
Recall initiated2025-10-06
Report date2025-11-05
Recall completed—
Recall numberD-0112-2026
ClassificationClass II
FDA statusOngoing
Origin on fileEast Brunswick NJ 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.