Imprimis Njof recalls

Imprimis Njof appears in 21 official U.S. recall notices indexed by RecallRadar, most recently on 2026-01-14.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-51…
  FDA Drug · Class II · 2026-01-14 · Imprimis Njof
  Reason: Presence of particulate matter - Glass like particles.
• Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 W…
  FDA Drug · Class II · 2026-01-14 · Imprimis Njof
  Reason: Presence of particulate matter - Glass like particles.
• Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West…
  FDA Drug · Class II · 2026-01-14 · Imprimis Njof
  Reason: Presence of particulate matter - Glass like particles.
• Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bott…
  FDA Drug · Class III · 2025-11-26 · Imprimis Njof
  Reason: Subpotent Drug
• Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Impr…
  FDA Drug · Class III · 2025-07-30 · Imprimis Njof
  Reason: Sub-Potent Drug: Subpotent assay results during stability testing.
• Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood…
  FDA Drug · Class II · 2025-07-30 · Imprimis Njof
  Reason: Sub-Potent Drug: Subpotent assay results during stability testing.
• Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis…
  FDA Drug · Class III · 2025-04-09 · Imprimis Njof
  Reason: Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
• Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug
  FDA Drug · Class II · 2024-06-19 · Imprimis Njof
  Reason: Lack of Assurance of Sterility
• Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis…
  FDA Drug · Class II · 2024-06-19 · Imprimis Njof
  Reason: Lack of Assurance of Sterility
• Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 17…
  FDA Drug · Class II · 2024-06-05 · Imprimis Njof
  Reason: Lack of Assurance of Sterility
• Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 Wes…
  FDA Drug · Class II · 2024-06-05 · Imprimis Njof
  Reason: Lack of Assurance of Sterility
• Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 170…
  FDA Drug · Class II · 2024-06-05 · Imprimis Njof
  Reason: Lack of Assurance of Sterility
• Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection,…
  FDA Drug · Class II · 2024-06-05 · Imprimis Njof
  Reason: Lack of Assurance of Sterility
• Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF,…
  FDA Drug · Class II · 2024-06-05 · Imprimis Njof
  Reason: Lack of Assurance of Sterility
• Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 W…
  FDA Drug · Class II · 2024-06-05 · Imprimis Njof
  Reason: Lack of Assurance of Sterility
• Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West…
  FDA Drug · Class III · 2024-05-08 · Imprimis Njof
  Reason: Out of specification for assay
• Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC.…
  FDA Drug · Class II · 2024-05-08 · Imprimis Njof
  Reason: Subpotent Drug
• MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle,…
  FDA Drug · Class III · 2023-10-25 · Imprimis Njof
  Reason: Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
• Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale
  FDA Drug · Class III · 2023-10-11 · Imprimis Njof
  Reason: Subpotent: Failing Test Results for Epinephrine
• Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood,…
  FDA Drug · Class III · 2023-08-30 · Imprimis Njof
  Reason: Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
• Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgew…
  FDA Drug · Class II · 2021-01-06 · Imprimis Njof
  Reason: Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.