Class II · ModerateRecall completed
Budesonide
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #s: GA20080, GA20081, GA20094, Exp. 01/2024
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
Lack of Assurance of Sterility
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 byCipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ foreign manufacturer
| Brand name | BUDESONIDE |
| Generic name | BUDESONIDE |
| Active ingredient(s) | BUDESONIDE |
| Distributed by / for | Cipla USA Inc., Warren NJ |
| NDC | 69097-318-86 |
Show the full FDA record
| Full product label | Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86. |
| Recalling firm | CIPLA |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 641,160 ampules |
| Recall initiated | 2022-09-15 |
| Report date | 2022-10-05 |
| Recall completed | 2024-01-10 |
| Recall number | D-1545-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Warren 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.