CLASS II ONGOING Drug recall · Reported 14 Jan 2026 · FDA Enforcement Report
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL recalled
Imprimis Njof is recalling Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use, distributed nationwide in the US. The recall was initiated on 18 Dec 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0250-2026
- FDA event ID
- 98181
- Recalling firm
- Imprimis Njof, Ledgewood, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Dec 2025
- FDA classified
- 2 Jan 2026
- Reported
- 14 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 18 Dec 2025 | Recall initiated by company | |
| 2 Jan 2026 | Classified by FDA | +15 days |
| 14 Jan 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter - Glass like particles.
Product as listed by the FDA
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.
Where it was distributed
U.S Nationwide
Questions about this recall
Why was it recalled?
Presence of particulate matter - Glass like particles.
Which lots are affected?
Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.
Where was it sold?
U.S Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98181This product is part of a recall event; the main page for the event is Tri-Moxi+¿ (Triamcinolone 9mg recalled by Imprimis NJOF.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tri-Moxi+¿ (Triamcinolone 9mg recalled by Imprimis NJOF | Imprimis Njof | Particulate Matter | Nationwide | |
| CLASS II | Dexamethasone Moxifloxacin, 1 mg/mL recalled by Imprimis NJOF | Imprimis Njof | Particulate Matter | Nationwide |
More recalls from Imprimis Njof
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Moxifloxacin, 1 mg/mL recalled by Imprimis NJOF | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS II | Tri-Moxi+¿ (Triamcinolone 9mg recalled by Imprimis NJOF | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS III | Klarity-C Drops (Cyclosporine) recalled by Imprimis NJOF | Imprimis Njof | Potency & Assay | Nationwide |
| Drug | CLASS II | Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, mL Vials recalled | Imprimis Njof | Potency & Assay | Nationwide |
| Drug | CLASS III | Tropicamide-Proparacaine-Phenylephrine-Ketorolac recalled | Imprimis Njof | Potency & Assay | Nationwide |
Other Dexamethasone Moxifloxacin Ketorolac recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL recalled | Imprimis Njof | Sterility | Nationwide |