FDAHealthDecember 19, 2025
Zydus Pharmaceuticals (USA) Inc — traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc.
⚠️ Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 19, 2025
Nationwide in the USA
What's affected?
- 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
- UPC
- 0368382808011
- Lot code
- EA00237A
Additional details
Lot # EA00237A, Exp Date: 04/30/2027
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 2,136 1000-count bottles.
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