FDA Recall D-0112-2026

Heritage Pharmaceuticals Inc · East Brunswick, NJ

Class II Ongoing 220 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

Lot / code: Lot#: 18035739, Exp. Date: 11/30/2025

Quantity: 3,750 bottles.

Reason for recall

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

Recall record

Recall number: D-0112-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide.
Recall initiated: 2025-10-06
Classified by FDA Center: 2025-10-27
FDA published: 2025-11-05
Recalling firm: Heritage Pharmaceuticals Inc
Firm location: East Brunswick, NJ

Drug identification

Brand name(s): DESIPRAMINE HYDROCHLORIDE
Generic name(s): DESIPRAMINE HYDROCHLORIDE
Manufacturer(s): Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC(s): 23155-578, 23155-579, 23155-580, 23155-581, 23155-582, 23155-583
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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