Class I · Most seriousRecall completed
TraZODONE Hydrochloride Tablets USP 100 mg
A reasonable chance it could cause serious harm or death.
Does this affect you?
Check your lot numberLot: 36783 Exp. 06/2022
Where it was soldNationwide within the U.S.
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
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
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
| Distributed by / for | AvKARE Pulaski, TN 38478 |
| NDC | 42291-834-10 |
Show the full FDA record
| Full product label | TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10 |
| Recalling firm | AVKARE Inc. |
| Distribution | Nationwide within the U.S. |
| Quantity | 14368 bottles |
| Recall initiated | 2020-12-07 |
| Report date | 2020-12-23 |
| Recall completed | 2023-10-16 |
| Recall number | D-0168-2021 |
| Classification | Class I |
| FDA status | Terminated |
| Origin on file | Pulaski TN 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.