Trazodone Hydrochloride Tablet
FDA Recall NDC 68382-609
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Trazodone Hydrochloride (NDC 68382-609). A significant event, classified as Class III, was initiated on Dec 19, 2025 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Dec 19, 2025
Jan 07, 2026
2,136 1000-count bottles
Recall Profile & Regulatory Data
Event ID
98184
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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
Batch or Lot Expiration Information
Lot# EA00237A, Exp Date: 04/30/2027
Affected Packages Involved in this Recall
68382-805-01Product
68382-805-30Product
68382-805-77Product
68382-805-05Product
68382-805-10Product
68382-805-06Product
68382-805-16Product
68382-806-06Product
68382-806-16Product
68382-806-01Product
68382-806-05Product
68382-806-10Product
68382-806-30Product
68382-806-77Product
68382-807-06Product
68382-807-16Product
68382-807-01Product
68382-807-05Product
68382-807-10Product
68382-807-30Product
68382-807-77Product
68382-808-06Product
68382-808-16Product
68382-808-01Product
68382-808-05Product
68382-808-10Product
68382-808-30Product
68382-808-77Product
68382-609-01Product
68382-609-05Product
68382-609-10Product
68382-610-01Product
68382-610-05Product
68382-610-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
