⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Zydus Pharmaceuticals (USA) Inc: traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus

DrugsSource: FDA (drug) · Date: 2026-01-07

Read the official notice at FDA (drug) →

Share on XFacebookRedditEmail

Get alerts for Zydus Pharmaceuticals

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Zydus Pharmaceuticals (USA) Inc
Product
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
Reason / hazard
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Classification
Class III
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2025-12-19
Code info
Lot # EA00237A, Exp Date: 04/30/2027
Product quantity
2,136 1000-count bottles
Voluntary mandated
Voluntary: Firm initiated
City
Pennington
State
NJ
Country
United States
Event id
98184
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.