Medications & Supplements/Prescription Drugs

Desipramine Hydrochloride Tablets Recalled for Excessive Impurities

Agency Publication Date: October 27, 2025

Summary

Heritage Pharmaceuticals Inc. is recalling approximately 33,663 bottles of Desipramine Hydrochloride Tablets, USP, across multiple strengths (10 mg to 150 mg). The recall was initiated because the medication contains N-Nitroso Desipramine at levels that exceed the permissible daily intake. This issue was discovered during quality control testing for current good manufacturing practice (CGMP) deviations.

Risk

The tablets contain a nitrosamine impurity called N-Nitroso Desipramine which exceeds safe daily limits. Long-term exposure to certain nitrosamines above acceptable levels may increase the risk of developing cancer.

What You Should Do

Check your medication bottles for Desipramine Hydrochloride Tablets in 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg strengths.
Compare the lot numbers and expiration dates on your prescription bottle or packaging to the affected list. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Desipramine Hydrochloride Tablets, USP (100 - count bottle)

Variants: 10 mg

Lot Numbers:

18036908 (Exp. Date: 09/30/2026)

NDC:

23155-578-01

Manufactured by: USV Private Limited, Daman, India; Manufactured for: Avet Pharmaceuticals Inc.

Product: Desipramine Hydrochloride Tablets, USP (100 count bottle)

Variants: 25 mg

Lot Numbers:

18035876 (Exp Date: 12/31/2025)

18036909 (Exp Date: 09/30/2026)

NDC:

23155-579-01

Manufactured by: USV Private Limited, Daman, India; Manufactured for: Avet Pharmaceuticals Inc.

Product: Desipramine Hydrochloride Tablets, USP (100 count bottle)

Variants: 50 mg

Lot Numbers:

18036713 (Exp Date: 08/31/2026)

NDC:

23155-580-01

Manufactured by: USV Private Limited, Daman, India; Manufactured for: Avet Pharmaceuticals Inc.

Product: Desipramine Hydrochloride Tablets, USP (100 count bottle)

Variants: 75 mg

Lot Numbers:

18036662 (Exp. Date: 07/31/2026)

18037649 (Exp. Date: 03/31/2027)

NDC:

23155-581-01

Manufactured by: USV Private Limited, Daman, India; Manufactured for: Avet Pharmaceuticals Inc.

Product: Desipramine Hydrochloride Tablets, USP (100 count bottle)

Variants: 100 mg

Lot Numbers:

18035574 (Exp. Date 10/31/2025)

18036758 (Exp. Date 08/31/2026)

NDC:

23155-582-01

Manufactured by: USV Private Limited, Daman, India; Manufactured for: Avet Pharmaceuticals Inc.

Product: Desipramine Hydrochloride Tablets, USP (50 count bottle)

Variants: 150 mg

Lot Numbers:

18035739 (Exp. Date: 11/30/2025)

NDC:

23155-583-25

Manufactured by: USV Private Limited, Daman, India; Manufactured for: Avet Pharmaceuticals Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97770

Status: Active

Manufacturer: Heritage Pharmaceuticals Inc

Sold By: Retail Pharmacies

Manufactured In: India, United States

Units Affected: 6 products (6,979 bottles.; 8,754 bottles.; 5880 bottles.; 2,418 bottles.; 5,882 bottles.; 3,750 bottles.)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication bottles for Desipramine Hydrochloride Tablets in 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg strengths.

Compare the lot numbers and expiration dates on your prescription bottle or packaging to the affected list. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Desipramine Hydrochloride Tablets, USP (100 - count bottle)

Variants: 10 mg

Lot Numbers:

18036908 (Exp. Date: 09/30/2026)

NDC:

23155-578-01

Manufactured by: USV Private Limited, Daman, India; Manufactured for: Avet Pharmaceuticals Inc.

Product: Desipramine Hydrochloride Tablets, USP (100 count bottle)

Variants: 25 mg

Lot Numbers:

18035876 (Exp Date: 12/31/2025)

18036909 (Exp Date: 09/30/2026)

NDC:

23155-579-01

Manufactured by: USV Private Limited, Daman, India; Manufactured for: Avet Pharmaceuticals Inc.

Product: Desipramine Hydrochloride Tablets, USP (100 count bottle)

Variants: 50 mg

Lot Numbers:

18036713 (Exp Date: 08/31/2026)

NDC:

23155-580-01

Manufactured by: USV Private Limited, Daman, India; Manufactured for: Avet Pharmaceuticals Inc.

Product: Desipramine Hydrochloride Tablets, USP (100 count bottle)

Variants: 75 mg

Lot Numbers:

18036662 (Exp. Date: 07/31/2026)

18037649 (Exp. Date: 03/31/2027)

NDC:

23155-581-01

Manufactured by: USV Private Limited, Daman, India; Manufactured for: Avet Pharmaceuticals Inc.

Product: Desipramine Hydrochloride Tablets, USP (100 count bottle)

Variants: 100 mg

Lot Numbers:

18035574 (Exp. Date 10/31/2025)

18036758 (Exp. Date 08/31/2026)

NDC:

23155-582-01

Manufactured by: USV Private Limited, Daman, India; Manufactured for: Avet Pharmaceuticals Inc.

Product: Desipramine Hydrochloride Tablets, USP (50 count bottle)

Variants: 150 mg

Lot Numbers:

18035739 (Exp. Date: 11/30/2025)

NDC:

23155-583-25

Manufactured by: USV Private Limited, Daman, India; Manufactured for: Avet Pharmaceuticals Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97770

Status: Active

Manufacturer: Heritage Pharmaceuticals Inc

Sold By: Retail Pharmacies

Manufactured In: India, United States

Units Affected: 6 products (6,979 bottles.; 8,754 bottles.; 5880 bottles.; 2,418 bottles.; 5,882 bottles.; 3,750 bottles.)

Distributed To: Nationwide