TRAZODONE HYDROCHLORIDE
Recalling Firm / Manufacturer: Granules Pharmaceuticals Inc.
(Chantilly, VA, United States)
FDA Recall Number: D-0305-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
TRAZODONE HYDROCHLORIDE
Generic Name
TRAZODONE HYDROCHLORIDE
Active Substance(s)
Trazodone Hydrochloride
Administration Route
Oral
National Drug Code (NDC)
70010-231
Total Quantity Recalled
71424 bottles.
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Presence of Foreign Tablets/Capsules
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
February 11, 2026
Firm Initiation Date
January 26, 2026
FDA Classification Date
Feb 11, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Batch # 6160008A, Exp Date: 12/31/2026
Distribution Information
Geographic scope of affected shipments
US Nationwide.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0305-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC