Class II · ModerateRecall completed
Difluprednate
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2, Exp 01/2023; DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2, Exp 02/2023; DEG1LC2, DEG2LC2, Exp 05/2023; DEG1BD2, DEG2BD2, DEG3BD2, Exp 07/2023
Where it was soldNationwide 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
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise 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., NJ 07059 foreign manufacturer
| Brand name | DIFLUPREDNATE |
| Generic name | DIFLUPREDNATE |
| Active ingredient(s) | DIFLUPREDNATE |
| Distributed by / for | Cipla USA, Inc., NJ 07059 |
| NDC | 69097-341-35 |
Show the full FDA record
| Full product label | Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35. |
| Recalling firm | CIPLA |
| Distribution | Nationwide in the USA |
| Quantity | 117,844 bottles |
| Recall initiated | 2022-08-22 |
| Report date | 2022-09-14 |
| Recall completed | 2023-11-27 |
| Recall number | D-1499-2022 |
| 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.