Drug 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-
Zydus Pharmaceuticals (USA) Inc · December 19, 2025
Reason for Recall
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
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
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
2,136 1000-count bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0247-2026
Status: ongoing
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