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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About This Product

TraZODONE Hydrochloride is an antidepressant medication commonly prescribed for depression and anxiety disorders. Consumers typically purchase it to manage their mental health conditions effectively.

Why This Is Dangerous

The dented tablets may not deliver the intended dosage of the medication, potentially leading to ineffective treatment. This defect raises concerns about the quality and consistency of the drug.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers must stop using the recalled tablets to avoid potential health risks. The immediate need for replacement or refund may cause some inconvenience.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on the bottle for EA00237A.
  2. Inspect the tablets for any visible dents on the plain side.
  3. Verify the expiration date, which should be April 30, 2027.

Where to find product info

The lot number and expiration date can be found on the label of the bottle.

What timeline to expect

Expect a refund processing timeline of 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Document all communications with Zydus Pharmaceuticals.
  • Follow up with the company if there is no response within two weeks.
  • Consider contacting the FDA if the issue remains unresolved.

How to prevent similar issues

  • Always inspect medication for visible defects before use.
  • Purchase drugs from reputable pharmacies or distributors.
  • Be aware of recall announcements from the FDA.

Documentation advice

Keep a record of receipts, recall notices, and any communication with the manufacturer.

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.

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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