traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Di
Summary
The FDA issued a Class III for traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufacture by Zydus Pharmaceuticals (USA) Inc. Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface..
Details
Source
Drug Recall
External ID
D-0247-2026
Action Date
2026-01-07
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot # EA00237A, Exp Date: 04/30/2027
Quantity Affected: 2,136 1000-count bottles
Reason for Recall
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-19
Company
Pennington, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 21 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Zydus Pharmaceuticals (USA) Inc has 47 FDA actions in our database, including 47 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zydus Pharmaceuticals (USA) Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zydus Pharmaceuticals (USA) Inc have FDA actions?
Zydus Pharmaceuticals (USA) Inc has 47 FDA actions in our database, including 47 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0247-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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