PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: July 30, 2025 Initiated: July 9, 2025 #D-0535-2025

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Imprimis NJOF, LLC
Units Affected
6,880 vials
Distribution
Nationwide in the USA
Location
Ledgewood, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Imprimis NJOF, LLC. Units affected: 6,880 vials.
Why was this product recalled?
Sub-Potent Drug: Subpotent assay results during stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 30, 2025. Severity: Moderate. Recall number: D-0535-2025.