D-0305-2026 Class II Ongoing
FDA drug recall D-0305-2026 was initiated by Granules Pharmaceuticals Inc. on Jan 26, 2026 and is designated Class II. Reason for recall: Presence of Foreign Tablets/Capsules The recall status is ongoing. Affected quantity: 71424 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 11, 2026
- Initiation Date
- Jan 26, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71424 bottles.
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
Distribution Pattern
US Nationwide.
Code Information
Batch # 6160008A, Exp Date: 12/31/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0305-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026