Zydus Pharmaceuticals (USA) Inc recalls traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, D…

Recall date

December 19, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0247-2026

FDA classification

Class III

Brand / firm

Zydus Pharmaceuticals (USA) Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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