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Low risk Drugs & MedicationsClass III

Zydus Trazodone 100mg Tablets Recall

TraZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus

Updated December 19, 2025

Zydus Pharmaceuticals is recalling trazodone 100 mg tablets due to some tablets having dents on the surface. Contact your pharmacist or doctor before stopping or replacing your medication.

Is the Zydus Pharmaceuticals (USA) Inc recalled? Yes. This product was recalled by FDA on December 19, 2025. Details below.

What is recalled

Trazodone Hydrochloride Tablets, USP, 100 mg, 1,000-tablet bottles, NDC 68382-806-10, manufactured by Zydus Lifesciences Ltd. (India) and distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.

Am I affected

You're affected if you have a prescription bottle of trazodone 100 mg tablets with NDC number 68382-806-10 on the label. Check the bottle for any tablets with visible dents on the plain side of the surface.

What to do right now

Contact your pharmacy or prescribing doctor. Do not stop taking trazodone without medical guidance. Your pharmacist can inspect your bottle, confirm whether it is part of this recall, and provide a replacement if needed.

The hazard

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

Brands affected

Zydus Pharmaceuticals (USA) Inc
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0247-2026
Classification
Class III
Recalled
December 19, 2025
Read the official notice

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