HIGH

Zydus Pharmaceuticals Recalls TraZODONE Tablets Over Defects

Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Quick Facts at a Glance

Recall Date
December 19, 2025
Hazard Level
HIGH
Brands
Zydus Pharmaceuticals, TraZODONE HYDROCHLORIDE
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter

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Product Details

The recall involves TraZODONE Hydrochloride Tablets, USP, 100mg, sold in 1,000-count bottles. The affected lot number is EA00237A with an expiration date of April 30, 2027. The product was distributed nationwide in the USA.

The Hazard

Some TraZODONE tablets may have dents on the plain side of the tablet surface. This defect could potentially affect the medication's effectiveness.

What to Do

Stop using the recalled TraZODONE tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc for further guidance and potential refund instructions.

Contact Information

For more information, consumers can call Zydus Pharmaceuticals at the number listed on the recall letter or visit the FDA recall page.

Key Facts

  • Recall date: December 19, 2025
  • Quantity: 2,136 bottles recalled
  • Manufactured by Zydus Lifesciences Ltd., India
  • Distributed by Zydus Pharmaceuticals (USA) Inc.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
6/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot # EA00237A
UPC Codes
68382-805
68382-806
68382-807
+11 more
Affected States
ALL
Report Date
January 7, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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