Zydus Pharmaceuticals recalls 100mg traZODONE tablets with a dent on the surface due to manufacturing defect. This may affect safety but does not cause serious injury. Check NDC 68382-806-10 and lot # EA00237A for affected units.
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Zydus Pharmaceuticals is recalling 100mg traZODONE hydrochloride tablets that have a dent on the surface. This defect could potentially affect the tablet's integrity but does not pose a serious injury risk in normal use.
The tablets have a dent on the plain side, which could lead to the tablet breaking during use. This might affect the medication's integrity but does not cause serious injury in normal use.
Prescription holders of Zydus traZODONE 100mg tablets with NDC 68382-806-10 and lot # EA00237A are affected. Patients taking this medication are most at risk if the dent causes the tablet to break during use.
Check for a dent on the plain side of the tablet. Affected units have NDC 68382-806-10 and lot number EA00237A, manufactured in India and distributed by Zydus Pharmaceuticals (USA) Inc.
Look for a dent on the plain side of the tablet. If found, stop using the tablet.
No, the dent does not cause serious injury in normal use. The hazard is low risk.
Check for a dent on the plain side of the tablet. Affected units have NDC 68382-806-10 and lot # EA00237A.
If you find a dent, stop using the tablet. Contact your doctor for alternative medication.
We’ve drafted a message you can send Zydus to request your refund or repair — edit it as you like.
Subject: Recall D-0247-2026 — Zydus Zydus Hello, I own a Zydus that is covered by recall D-0247-2026 from Zydus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
