Desipramine Hydrochloride
FDA Recall NDC 23155-583
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 6 recorded enforcement report(s) associated with Desipramine Hydrochloride (NDC 23155-583). A significant event, classified as Class II, was initiated on Oct 06, 2025 by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The reported reason for this action was: "CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Oct 06, 2025
Nov 05, 2025
6,979 bottles.
Recall Profile & Regulatory Data
Event ID
97770
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Heritage Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Batch or Lot Expiration Information
Lot# : 18036908, Exp. Date: 09/30/2026
Affected Packages Involved in this Recall
23155-578-01Product
23155-579-01Product
23155-580-01Product
23155-581-01Product
23155-582-01Product
23155-583-25Product
Class II Ongoing
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Oct 06, 2025
Nov 05, 2025
8,754 bottles.
Recall Profile & Regulatory Data
Event ID
97770
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Heritage Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Batch or Lot Expiration Information
Lot# : 18035876, Exp Date: 12/31/2025
Lot# : 18036909, Exp Date: 09/30/2026
Affected Packages Involved in this Recall
23155-578-01Product
23155-579-01Product
23155-580-01Product
23155-581-01Product
23155-582-01Product
23155-583-25Product
Class II Ongoing
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Oct 06, 2025
Nov 05, 2025
5,882 bottles.
Recall Profile & Regulatory Data
Event ID
97770
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Heritage Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Batch or Lot Expiration Information
Lot# : 18035574, Exp. Date 10/31/2025
Lot# : 18036758, Exp. Date 08/31/2026
Affected Packages Involved in this Recall
23155-578-01Product
23155-579-01Product
23155-580-01Product
23155-581-01Product
23155-582-01Product
23155-583-25Product
Class II Ongoing
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Oct 06, 2025
Nov 05, 2025
3,750 bottles.
Recall Profile & Regulatory Data
Event ID
97770
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Heritage Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
Desipramine 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.
Batch or Lot Expiration Information
Lot# : 18035739, Exp. Date: 11/30/2025
Affected Packages Involved in this Recall
23155-578-01Product
23155-579-01Product
23155-580-01Product
23155-581-01Product
23155-582-01Product
23155-583-25Product
Class II Ongoing
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Oct 06, 2025
Nov 05, 2025
5880 bottles.
Recall Profile & Regulatory Data
Event ID
97770
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Heritage Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
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.
Batch or Lot Expiration Information
Lot# :18036713, Exp Date: 08/31/2026
Affected Packages Involved in this Recall
23155-578-01Product
23155-579-01Product
23155-580-01Product
23155-581-01Product
23155-582-01Product
23155-583-25Product
Class II Ongoing
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Oct 06, 2025
Nov 05, 2025
2,418 bottles.
Recall Profile & Regulatory Data
Event ID
97770
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Heritage Pharmaceuticals Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide.
Product Description
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Batch or Lot Expiration Information
Lot# : 18036662, Exp. Date: 07/31/2026
Lot# : 18037649, Exp. Date: 03/31/2027
Affected Packages Involved in this Recall
23155-578-01Product
23155-579-01Product
23155-580-01Product
23155-581-01Product
23155-582-01Product
23155-583-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
