Trazodone Hydrochloride Tablet
FDA Recall NDC 70010-232
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 70010-232). A significant event, classified as Class II, was initiated on Jan 26, 2026 by Granules Pharmaceuticals 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
Jan 26, 2026
Feb 11, 2026
71424 bottles.
Recall Profile & Regulatory Data
Event ID
98345
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Granules Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
Batch or Lot Expiration Information
Batch# 6160008A, Exp Date: 12/31/2026
Affected Packages Involved in this Recall
70010-231-03Product
70010-231-01Product
70010-231-05Product
70010-231-10Product
70010-232-03Product
70010-232-01Product
70010-232-05Product
70010-232-10Product
70010-233-03Product
70010-233-01Product
70010-233-05Product
70010-234-03Product
70010-234-01Product
70010-234-05Product
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.
