trazodone hydrochloridedrugHigh PriorityActive

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

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

By RecallRadar Editorial Team

Sourced from FDA. Last reviewed March 4, 2026.

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

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.

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

What You Should Do

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.

Open Official Recall Notice Get Alerts for trazodone hydrochloride Devices

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.

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.

Frequently Asked Questions

Is my trazodone hydrochloride device affected?

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: trazodone hydrochloride recall hub and Food & Drug recall hub.