Why it was recalled
Presence of particulate matter - Glass like particles.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.
Where it was sold
U.S Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0250-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 18, 2025
- FDA report date
- Jan 14, 2026
- Quantity
- 596 boxes of 11,920 pre-filled syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Imprimis NJOF, LLC
Original FDA data
Every field from FDA enforcement report D-0250-2026, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98181
- Address
- 1705 Route 46 Ste 6B
- Code information
- Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.
- Postal code
- 07852-9720
- Report date
- Jan 14, 2026
- Product type
- Drugs
- Recall number
- D-0250-2026
- Classification
- Class II
- Recalling firm
- Imprimis NJOF, LLC
- Product quantity
- 596 boxes of 11,920 pre-filled syringes
- Reason for recall
- Presence of particulate matter - Glass like particles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S Nationwide
- Recall initiation date
- Dec 18, 2025
- Initial firm notification
- Letter
- Center classification date
- Jan 2, 2026