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Drug FDA Class II Completed Sub/super-potent

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

Imprimis NJOF, LLC Published Jul 30, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Imprimis NJOF, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Subpotency · primary

Affected products (1)

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

Lot codes: 24DEC017
Code info: Lot: 24DEC017, Exp. 07/12/2025.

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 9, 2025
  2. Published
    Jul 30, 2025
Recall number
D-0535-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.