Granules Pharmaceuticals Inc. recalls Trazodone Hydrochloride
- Recalling company
- Granules Pharmaceuticals Inc.
- Product
- 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
- Presence of Foreign Tablets/Capsules
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jan 26, 2026
- Reported
- Feb 11, 2026
- Distribution
- US Nationwide.
- Status
- Ongoing
- Quantity
- 71424 bottles.
- Lot / codes
- Batch # 6160008A, Exp Date: 12/31/2026
- Company location
- Chantilly, VA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0305-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0305-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.