Home/Recalls/FDA-D-0249-2026
FDA DrugsClass II

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, R...

Published: January 14, 2026Recall ID: D-0249-2026Category: drugsCountry: US

Reason for Recall / Hazard

Presence of particulate matter - Glass like particles.

Product Description & Identification

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1

Affected Products

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1

Additional Source Details

FieldValue
CityLedgewood
StateNJ
Event id98181
Address 11705 Route 46 Ste 6B
Code infoLot: 25MAY051, Expires: 06/26/2026; 25AUG003, Expires:08/07/2026
Postal code07852-9720
Report date20260114
Product typeDrugs
Product quantity778 boxes of 15,540 pre-filled syringes
Reason for recallPresence of particulate matter - Glass like particles.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20251218
Initial firm notificationLetter
Center classification date20260102

Overview

  • Recalling FirmImprimis NJOF, LLC
  • StatusOngoing
  • Risk LevelClass II
  • DistributionU.S Nationwide
Official Agency Alert