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
Reported: January 7, 2026 Initiated: December 19, 2025 #D-0247-2026
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
Reason for Recall
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Details
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Units Affected
- 2,136 1000-count bottles
- Distribution
- Nationwide in the USA
- Location
- Pennington, NJ
Frequently Asked Questions
What product was recalled? ▼
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 Zydus Pharmaceuticals (USA) Inc. Units affected: 2,136 1000-count bottles.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 7, 2026. Severity: Low. Recall number: D-0247-2026.
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