Recalls / Class II
Class IID-0305-2026
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.
- Brand name
- Trazodone Hydrochloride
- Generic name
- Trazodone Hydrochloride
- Active ingredient
- Trazodone Hydrochloride
- Route
- Oral
- NDCs
- 70010-231, 70010-232, 70010-233, 70010-234
- FDA application
- ANDA218988
- Affected lot / code info
- Batch # 6160008A, Exp Date: 12/31/2026
Why it was recalled
Presence of Foreign Tablets/Capsules
Recalling firm
- Firm
- Granules Pharmaceuticals Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 3701 Concorde Pkwy, N/A, Chantilly, Virginia 20151-1126
Distribution
- Quantity
- 71424 bottles.
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2026-01-26
- FDA classified
- 2026-02-11
- Posted by FDA
- 2026-02-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0305-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.