Warning
Heritage Pharmaceuticals Inc Recalls Desipramine Hydrochloride Tablets
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0108-2026Drug / Pharmaceutical
Heritage Pharmaceuticals Inc Recalls Desipramine Hydrochloride Tablets
Heritage Pharmaceuticals Inc · Class II — Moderate Risk
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.
Reason for Recall
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S. Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Heritage Pharmaceuticals Inc initiated the recall on October 6, 2025 affecting 8,754 bottles. CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. The product was distributed in U.S. Nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Heritage Pharmaceuticals Inc for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.