FDAClass IIIJanuary 7, 2026

traZODONE Hydrochloride Tablets 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

Why was traZODONE Hydrochloride Tablets recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # EA00237A, Exp Date: 04/30/2027

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
Recalling firm
Zydus Pharmaceuticals (USA) Inc
Quantity
2,136 1000-count bottles
Distribution
Nationwide in the USA
Recall date
January 7, 2026
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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