Class III · Lower riskRecall completed
Albuterol Sulfate Inhalation Solution
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: GA51265, Ex[p. Jan-2017, GA51454, GA51553, GA51583, Exp. Feb-2017, GA51598, GA51724, GA51725, GA51749, Exp. Mar-2017
Where it was soldNationwide in the US
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 Impurities/Degradation Specifications: Product is out of specification for a known degradant.
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 | Actavis Inc |
| NDC | 0591-3467-53 |
Show the full FDA record
| Full product label | Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53 |
| Recalling firm | Actavis Inc |
| Distribution | Nationwide in the US |
| Quantity | 164,844 units |
| Recall initiated | 2017-01-12 |
| Report date | 2017-02-01 |
| Recall completed | 2018-03-05 |
| Recall number | D-0439-2017 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Parsippany NJ 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.