TRAZODONE HYDROCHLORIDE
Recalling Firm / Manufacturer: Zydus Pharmaceuticals (USA) Inc
(Pennington, NJ, United States)
FDA Recall Number: D-0247-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
TRAZODONE HYDROCHLORIDE
Generic Name
TRAZODONE HYDROCHLORIDE
Active Substance(s)
Trazodone Hydrochloride
Administration Route
Oral
National Drug Code (NDC)
68382-609
Total Quantity Recalled
2,136 1000-count bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Full Product Description
Packaging specifications and labeling details
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
January 07, 2026
Firm Initiation Date
December 19, 2025
FDA Classification Date
Dec 31, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot # EA00237A, Exp Date: 04/30/2027
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0247-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508608UTCC