Class II · ModerateRecall completed
Xanax XR (alprazolam) extended-release tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: DX7983, exp. date 02/28/2023
Where it was soldProduct was distributed nationwide in the USA
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
Failed Dissolution Specifications: low out of specification results for dissolution.
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 | Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017 |
| NDC | 0009-0068-07 |
Show the full FDA record
| Full product label | Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07. |
| Recalling firm | Viatris Inc |
| Distribution | Product was distributed nationwide in the USA |
| Quantity | 110 bottles |
| Recall initiated | 2022-04-28 |
| Report date | 2022-05-18 |
| Recall completed | 2023-07-13 |
| Recall number | D-0854-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Canonsburg PA 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.