CLASS II Drug recall · Reported 30 Jul 2025 · FDA Enforcement Report
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, mL Vials recalled
Imprimis Njof is recalling Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, mL Vials per, distributed nationwide in the US. The recall was initiated on 9 Jul 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0535-2025
- FDA event ID
- 97183
- Recalling firm
- Imprimis Njof, Ledgewood, NJ
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 9 Jul 2025
- FDA classified
- 21 Jul 2025
- Reported
- 30 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 9 Jul 2025 | Recall initiated by company | |
| 21 Jul 2025 | Classified by FDA | +12 days |
| 30 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub-Potent Drug: Subpotent assay results during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Sub-Potent Drug: Subpotent assay results during stability testing.
Which lots are affected?
Lot: 24DEC017, Exp. 07/12/2025.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97183This product is part of a recall event; the main page for the event is Tropicamide-Proparacaine-Phenylephrine-Ketorolac recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Tropicamide-Proparacaine-Phenylephrine-Ketorolac recalled | Imprimis Njof | Potency & Assay | Nationwide |
More recalls from Imprimis Njof
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Moxifloxacin, 1 mg/mL recalled by Imprimis NJOF | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS II | Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL recalled | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS II | Tri-Moxi+¿ (Triamcinolone 9mg recalled by Imprimis NJOF | Imprimis Njof | Particulate Matter | Nationwide |
| Drug | CLASS III | Klarity-C Drops (Cyclosporine) recalled by Imprimis NJOF | Imprimis Njof | Potency & Assay | Nationwide |
| Drug | CLASS III | Tropicamide-Proparacaine-Phenylephrine-Ketorolac recalled | Imprimis Njof | Potency & Assay | Nationwide |
Other Epinephrine Lidocaine recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Epinephrine-Lidocaine HCl 0.25 mg/mL recalled by Imprimis NJOF | Imprimis Njof | Sterility | Nationwide |
| Drug | CLASS II | Epinephrine-Lidocaine HCl 0.25 mg/mL recalled by Imprimis NJOF | Imprimis Njof | Sterility | Nationwide |
| Drug | CLASS III | Epinephrine-Lidocaine HCl 0.25 mg/mL recalled by Imprimis NJOF | Imprimis Njof | Potency & Assay | Nationwide |
| Drug | CLASS III | Epinephrine-Lidocaine HCl (0.25mg/mL recalled by Imprimis NJOF | Imprimis Njof | Potency & Assay | Nationwide |