traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifes...
FDA Recall #D-0247-2026 — Class III — December 19, 2025
Product Description
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
Reason for Recall
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Recalling Firm
Zydus Pharmaceuticals (USA) Inc — Pennington, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
2,136 1000-count bottles
Distribution
Nationwide in the USA
Code Information
Lot # EA00237A, Exp Date: 04/30/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated