← FDA ENFORCEMENT
D-0107-2026Class II

Heritage Pharmaceuticals Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Heritage Pharmaceuticals Inc
Product type
Drug
Status
Ongoing
Report date
2025-11-05
Distribution
U.S. Nationwide.
Firm state
NJ
Product quantity
6,979 bottles.
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

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.

Code / lot info

Lot#: 18036908, Exp. Date: 09/30/2026

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →