United StatestraZODONE Hydrochloride Tablets, USP, 100 mg, 1,000‑count bottles (NDC 68382‑806‑10), Lot EA00237A, Exp. 04/30/2027, distributed by Zydus Pharmaceuticals (USA) Inc., are being recalled; affected bottles were sold nationwide in the U.S. and some tablets may be identified by a dent on the plain side of the tablet surface. The recall was initiated after a product complaint that some tablets failed tablet/capsule specifications due to the dent.
What's being recalled
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
Recalling firm: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States.
How to identify it
Lot # EA00237A, Exp Date: 04/30/2027
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)