Zydus traZODONE 100mg Tablets Recall: Dent on Tablet Surface
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.
Lower-risk recall
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/31604-zydus-trazodone-100mg-tablets-recall-dent-on-tablet-surface.
Source Summary by GovInfoNow · govinfonow.com/recall/31604-zydus-trazodone-100mg-tablets-recall-dent-on-tablet-surface · Updated August 17, 2026 · FDA enforcement record: FDA #D-0247-2026
Cite this page
“Zydus traZODONE 100mg Tablets Recall: Dent on Tablet Surface.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31604-zydus-trazodone-100mg-tablets-recall-dent-on-tablet-surface. Based on FDA recall #D-0247-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0247-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Zydus- Category
Drug
What to do — step by step
Check Tablet Surface
Look for a dent on the plain side of the tablet. If found, stop using the tablet.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the recalled product?
If you find a dent, stop using the tablet. Contact your doctor for alternative medication.
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Where this comes from
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.
- Official source: FDA Recall #D-0247-2026 (December 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0247-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.