Drug recall: Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46…

Class II FDA enforcement event 97183. Recall start date: 9 Jul 2025. Status in the FDA record: Completed.

Reason for recall, in the words of FDA

Sub-Potent Drug: Subpotent assay results during stability testing.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Imprimis NJOF, LLC started this drug recall on 9 Jul 2025. The firm address in the FDA record is in Ledgewood, NJ. FDA put the recall in Class II. FDA event 97183 has 2 product records. The first FDA enforcement report date is 30 Jul 2025. The record gives the status Completed.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA

Recalling firm

Imprimis NJOF, LLC, Ledgewood, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 97183: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0535-2025	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, NJ, 07852 NDC: 71384-641-01	6,880 vials	Class II	Completed	30 Jul 2025
D-0536-2025	Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.	2,890 vials	Class III	Completed	30 Jul 2025

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2025: 322
Share of these events in Class II: 79%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 14

Other events of the firm

Other FDA enforcement events of Imprimis NJOF, LLC
Initiated	Product (first record)	Type	Class	Records
18 Dec 2025	Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ	Drug	Class II	3
20 Oct 2025	Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Us	Drug	Class III	1
24 Feb 2025	Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 m	Drug	Class III	1
14 May 2024	Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compo	Drug	Class II	1
14 May 2024	Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. N	Drug	Class II	1
14 May 2024	Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Impr	Drug	Class II	1
14 May 2024	Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imp	Drug	Class II	5
10 Apr 2024	Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC	Drug	Class III	1
10 Apr 2024	Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: I	Drug	Class II	1
3 Oct 2023	Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-	Drug	Class III	1

Imprimis NJOF, LLC: all 14 events

Official channels

FDA enforcement report D-0535-2025The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 97183. https://recallregister.com/fda/ii/97183/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA
What quantity of product is in FDA event 97183?: The event has 2 product records. The first record gives this quantity: 6,880 vials
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2025 have the same class?: 79% of the 322 drug events that started in 2025 are in Class II.