Trazodone Hydrochloride Tablet
FDA Recall NDC 50111-561
Latest: Class II · Status: Ongoing · Initiated Aug 24, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Trazodone Hydrochloride (NDC 50111-561). A significant event, classified as Class II, was initiated on Aug 24, 2026 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules"
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 II Ongoing
Presence of Foreign Tablets/Capsules
Aug 24, 2026
Sep 09, 2026
175,392 bottles
Recall Profile & Regulatory Data
Event ID
99734
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01
Batch or Lot Expiration Information
Lot# Lot: 1394026, Exp. 02/2028.
Affected Packages Involved in this Recall
50111-560-01Trazodone Hydrochloride
50111-560-02Trazodone Hydrochloride
50111-560-03Trazodone Hydrochloride
50111-561-01Trazodone Hydrochloride
50111-561-02Trazodone Hydrochloride
50111-561-03Trazodone Hydrochloride
50111-450-01Trazodone Hydrochloride
50111-450-02Trazodone Hydrochloride
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.
