Drug recall D-0247-2026

Class III Ongoing reported Jan 7, 2026

Product

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.

Lots and codes

Lot # EA00237A, Exp Date: 04/30/2027

Recall details

Recalling firm
Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Quantity
2,136 1000-count bottles
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
December 19, 2025

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