FDAFDA · Food and drugs·Recall number D-0247-2026
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
Published January 7, 2026 · Recall initiated: December 19, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TRAZODONE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Nationwide in the USA
- UPC
- 0368382808011
- Lot
- Lot # EA00237A, Exp Date: 04/30/2027
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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