FDA Recall D-0305-2026
Granules Pharmaceuticals Inc. · Chantilly, VA
Class II Ongoing 108 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 for recall
Presence of Foreign Tablets/Capsules
Recall record
- Recall number
D-0305-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- N/A
- Distribution
- US Nationwide.
- Recall initiated
- 2026-01-26
- Classified by FDA Center
- 2026-02-11
- FDA published
- 2026-02-11
- Recalling firm
- Granules Pharmaceuticals Inc.
- Firm location
- Chantilly, VA
Drug identification
- Brand name(s)
- TRAZODONE HYDROCHLORIDE
- Generic name(s)
- TRAZODONE HYDROCHLORIDE
- Manufacturer(s)
- Granules Pharmaceuticals Inc.
- NDC(s)
70010-231, 70010-232, 70010-233, 70010-234- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.