Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Desipramine Hydrochloride Tablets Recalled by Heritage Pharmaceuticals Inc Due to CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible...

Date: October 6, 2025
Company: Heritage Pharmaceuticals Inc
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Heritage Pharmaceuticals Inc directly.

Affected Products

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.

Quantity: 8,754 bottles.

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Heritage Pharmaceuticals Inc

Heritage Pharmaceuticals Inc has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report