Class II · ModerateActive recall
Albuterol Sulfate Syrup
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberAll Lots
Where it was soldNationwide in the USA and Puerto Rico
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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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 | Akorn Operating Company LLC, Gurnee, IL 60031. ALL |
Show the full FDA record
| Full product label | Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs |
| Recalling firm | Akorn, Inc. |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | N/A |
| Recall initiated | 2023-04-26 |
| Report date | 2023-06-07 |
| Recall completed | — |
| Recall number | D-0783-2023 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Gurnee IL 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.