DESIPRAMINE HYDROCHLORIDE
Recalling Firm / Manufacturer: Heritage Pharmaceuticals Inc
(East Brunswick, NJ, United States)
FDA Recall Number: D-0109-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
DESIPRAMINE HYDROCHLORIDE
Generic Name
DESIPRAMINE HYDROCHLORIDE
Active Substance(s)
Desipramine Hydrochloride
Administration Route
Oral
National Drug Code (NDC)
23155-578
Total Quantity Recalled
5880 bottles.
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Full Product Description
Packaging specifications and labeling details
Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
November 05, 2025
Firm Initiation Date
October 06, 2025
FDA Classification Date
Oct 27, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot#:18036713, Exp Date: 08/31/2026
Distribution Information
Geographic scope of affected shipments
U.S. Nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0109-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508609UTCC