Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India L...
FDA Recall #D-0305-2026 — Class II — January 26, 2026
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.
Reason for Recall
Presence of Foreign Tablets/Capsules
Recalling Firm
Granules Pharmaceuticals Inc. — Chantilly, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
71424 bottles.
Distribution
US Nationwide.
Code Information
Batch # 6160008A, Exp Date: 12/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated