Recall Ledger

Dexamethasone Moxifloxacin Ketorolac recall (Imprimis NJOF, LLC)

DrugClass IIOngoing

Summary: Imprimis NJOF, LLC is recalling 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.. Reason: Presence of particulate matter - Glass like particles.

What is being recalled

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.

Why

Presence of particulate matter - Glass like particles.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

U.S Nationwide

How to tell if yours is affected

Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0250-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedDecember 18, 2025
ReportedJanuary 14, 2026
CompanyImprimis NJOF, LLC
Company locationLedgewood, NJ, United States
Initiated byVoluntary: Firm initiated
Quantity596 boxes of 11,920 pre-filled syringes

More recalls from Imprimis NJOF, LLC · all drug recalls · recalls from December 2025

Official FDA record