Desipramine Hydrochloride Tablets recalled over manufacturing violations

Recall date

October 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Heritage Pharmaceuticals Inc recalls Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Priv…

Recall number

D-0111-2026

FDA classification

Class II

Brand / firm

Heritage Pharmaceuticals Inc

Sold / distributed

U.S. Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.