traZODONE Hydrochloride Recall
traZODONE Hydrochloride Tablets has been recalled due to failed tablet/capsule specifications: product complaint received that some tablets had a dent on the plain side of the tablet surface.. Consumers who purchased this product should stop using it immediately. Check the official FDA notice for specific lot numbers and return or disposal instructions.
By RecallRadar Editorial Team
Sourced from FDA. Last verified March 4, 2026.
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Check if you qualifyKey facts
- Date announced
- December 19, 2025
- Source agency
- FDA
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
traZODONE Hydrochloride Tablets has been recalled due to failed tablet/capsule specifications: product complaint received that some tablets had a dent on the plain side of the tablet surface.. Consumers who purchased this product should stop using it immediately. Check the official FDA notice for specific lot numbers and return or disposal instructions.
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
What's Being Recalled
Quoted source excerpt from the official notice.
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Quick Info
Key facts from the official notice, kept in the article flow for easy cross-checking.
- Brand
- Zydus lifesciences ltd.
- Category
- drug
- Source agency
- FDA
- Announced
- December 19, 2025
- Country
- US
- Status
- Active
Who's Affected
Specific models and identifiers listed in the source notice:
Model #1
Lot # EA00237A, Exp Date: 04/30/2027
| # | Model |
|---|---|
| 1 | Lot # EA00237A, Exp Date: 04/30/2027 |
Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.
What You Should Do
Follow the remedy path from the official notice using the exact model and serial details above.
- 1## 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 Agency: FDA | Category: drug Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. What to do:
- 2Stop using the product if your lot/model matches.
- 3Check the FDA notice for specifics.
- 4Follow remedy instructions.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- FDA
- Announced by source
- December 19, 2025
- Last reviewed by RecallRadar
- March 4, 2026
Frequently Asked Questions
Am I affected by this recall?
Check the affected models section on this page. The official notice currently lists Lot # EA00237A, Exp Date: 04/30/2027.
What is the remedy for this recall?
## 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 Agency: FDA | Category: drug Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Keep browsing with these internal hubs: Zydus Lifesciences Ltd. recall hub and Food & Drug recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
View official notice from FDASee an inaccuracy?
Help us improve the accuracy of this recall information.
On this page
Free checker
Check if you qualify
See whether your device may qualify for a free repair or replacement program before you spend money.
Check if you qualifyKey facts
- Date announced
- December 19, 2025
- Source agency
- FDA
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