Records and reported status
Dec 18, 2025 FDA drug enforcement
Presence of particulate matter - Glass like particles.
Class II Reported ongoing
Distribution: U.S Nationwide
Official source for Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJ... Dec 18, 2025 FDA drug enforcement
Presence of particulate matter - Glass like particles.
Class II Reported ongoing
Distribution: U.S Nationwide
Official source for Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injec... Dec 18, 2025 FDA drug enforcement
Presence of particulate matter - Glass like particles.
Class II Reported ongoing
Distribution: U.S Nationwide
Official source for Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injectio... Oct 20, 2025 FDA drug enforcement
Subpotent Drug
Class III Reported ongoing
Distribution: USA nationwide
Official source for Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a com... Jul 9, 2025 FDA drug enforcement
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II Reported completed
Distribution: Nationwide in the USA
Official source for Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis N... Jul 9, 2025 FDA drug enforcement
Sub-Potent Drug: Subpotent assay results during stability testing.
Class III Reported completed
Distribution: Nationwide in the USA
Official source for Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%,... Feb 24, 2025 FDA drug enforcement
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.
Class III Reported ongoing
Distribution: FL and NY
Official source for Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% ... May 14, 2024 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported ongoing
Distribution: Nationwide within the United States
Official source for Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Int... May 14, 2024 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported ongoing
Distribution: Nationwide within the United States
Official source for Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intra... May 14, 2024 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported ongoing
Distribution: Nationwide within the United States
Official source for Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL S... May 14, 2024 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported ongoing
Distribution: Nationwide within the United States
Official source for Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx... May 14, 2024 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported ongoing
Distribution: Nationwide within the United States
Official source for Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx o... May 14, 2024 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported ongoing
Distribution: Nationwide within the United States
Official source for Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intr... May 14, 2024 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported ongoing
Distribution: US Nationwide
Official source for Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This ... May 14, 2024 FDA drug enforcement
Lack of Assurance of Sterility
Class II Reported ongoing
Distribution: US Nationwide
Official source for Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantit... Apr 10, 2024 FDA drug enforcement
Subpotent Drug
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%... Apr 10, 2024 FDA drug enforcement
Out of specification for assay
Class III Reported ongoing
Distribution: Nationwide within the United States
Official source for Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx o... Oct 3, 2023 FDA drug enforcement
Subpotent: Failing Test Results for Epinephrine
Class III Reported terminated
Distribution: Nationwide
Official source for Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservat... Sep 20, 2023 FDA drug enforcement
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Class III Reported terminated
Distribution: Product was distributed to physician's offices nationwide.
Official source for MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution D... Aug 10, 2023 FDA drug enforcement
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Class III Reported terminated
Distribution: Nationwide in the US
Official source for Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LL...
Reasons in these listed records Presence of particulate matter - Glass like particles. Subpotent Drug Sub-Potent Drug: Subpotent assay results during stability testing. 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. These examples come from this result page and are not a ranking of every recall reason.
Checking Imprimis NJOF, LLC Is there a recall on imprimis njof, llc right now? This archive contains 20 records, including 15 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records? Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.