Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Privat
Summary
The FDA issued a Class II for Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-0 by Heritage Pharmaceuticals Inc. Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level..
Details
Source
Drug Recall
External ID
D-0110-2026
Action Date
2025-11-05
Status
Ongoing
Category
drug
Product Description
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Lot/Code Info: Lot#: 18036662, Exp. Date: 07/31/2026 Lot#: 18037649, Exp. Date: 03/31/2027
Quantity Affected: 2,418 bottles.
Reason for Recall
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Distribution
U.S. Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-06
Company
East Brunswick, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 95 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Heritage Pharmaceuticals Inc has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Heritage Pharmaceuticals Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Heritage Pharmaceuticals Inc have FDA actions?
Heritage Pharmaceuticals Inc has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0110-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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