Class II · ModerateActive recall
Trazodone Hydrochloride
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberBatch # 6160008A, Exp Date: 12/31/2026
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Presence of Foreign Tablets/Capsules
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byGranules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151 foreign manufacturer
| Brand name | TRAZODONE HYDROCHLORIDE |
| Generic name | TRAZODONE HYDROCHLORIDE |
| Active ingredient(s) | TRAZODONE HYDROCHLORIDE |
| Distributed by / for | Granules Pharmaceuticals Inc., Chantilly, VA 20151 |
| NDC | 70010-231-01 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Granules Pharmaceuticals Inc. |
| Distribution | US Nationwide. |
| Quantity | 71424 bottles. |
| Recall initiated | 2026-01-26 |
| Report date | 2026-02-11 |
| Recall completed | — |
| Recall number | D-0305-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Chantilly VA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.