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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Zydus Pharmaceuticals, TraZODONE HYDROCHLORIDE
- Product type
- TraZODONE Hydrochloride Tablets
- Model numbers
- Lot # EA00237A
- UPC codes
- 68382-805, 68382-806, 68382-807, 68382-808, 68382-805-16, 68382-805-01, 68382-805-05, 68382-805-10 +6 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 19, 2025
Reported by FDA DRUG
January 7, 2026
RecallRadar source check
January 14, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the lot number on the bottle for EA00237A.
- Inspect the tablets for any visible dents on the plain side.
- 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.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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.
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.