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-

Recall Summary Zydus Pharmaceuticals is recalling trazodone hydrochloride 100mg tablets (1,000-tablet bottles, NDC 68382-806-10) distributed nationwide because some tablets have dents on their surface that don't meet product specifications. This is a Class I recall, meaning there is a serious potential health hazard. The affected medication was manufactured by Zydus Lifesciences Ltd. in India and distributed across all 50 states and Washington, DC.

Recalling firm

Zydus Pharmaceuticals (USA) Inc

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

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

Classification

Class I

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2025-12-19

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide in the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/f09feead-c0c4-47dc-b6b0-06e0ef43431f