Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter
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The recall involves TraZODONE Hydrochloride Tablets, USP, 100mg, sold in 1,000-count bottles. The affected lot number is EA00237A with an expiration date of April 30, 2027. The product was distributed nationwide in the USA.
Some TraZODONE tablets may have dents on the plain side of the tablet surface. This defect could potentially affect the medication's effectiveness.
There have been no reported injuries or adverse events associated with this defect. The recall was initiated following a product complaint.
Stop using the recalled TraZODONE tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc for further guidance and potential refund instructions.
For more information, consumers can call Zydus Pharmaceuticals at the number listed on the recall letter or visit the FDA recall page.
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