FDA Drugs recall ·
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only… recall
- Recall number
- D-0305-2026
- Date
- (initiated January 26, 2026)
- Company / brand
- Granules Pharmaceuticals Inc.
3701 Concorde Pkwy, Chantilly, VA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 71424 bottles.
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Presence of Foreign Tablets/Capsules
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch # 6160008A, Exp Date: 12/31/2026
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0305-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.