Class II · ModerateActive recall
Dexamethasone Moxifloxacin Ketorolac
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot: 25APR001A, 25APR001B, Expires: 04/03/2026.
Where it was soldU.S Nationwide
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
Presence of particulate matter - Glass like particles.
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 | Imprimis NJOF, LLC |
| NDC | 71384-513-01 |
Show the full FDA record
| Full product label | Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01. |
| Recalling firm | Imprimis NJOF, LLC |
| Distribution | U.S Nationwide |
| Quantity | 596 boxes of 11,920 pre-filled syringes |
| Recall initiated | 2025-12-18 |
| Report date | 2026-01-14 |
| Recall completed | — |
| Recall number | D-0250-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Ledgewood 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.