The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0535-2025·Announced 2025-07-30

Compounded epinephrine lidocaine vials returned subpotent assay results in stability testing

Epinephrine Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL vials compounded by Imprimis NJOF are being recalled because of subpotent assay results during stability testing. 6,880 vials affected.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Risk-of-harm product: a subpotent local anaesthetic and vasoconstrictor may not achieve the intended clinical effect, with no injury reported in the source.

Plain-English summary

Epinephrine Lidocaine HCl, 0.25 mg/mL and 7.5 mg/mL, 20 x 1 mL vials per carton, prescription only, from Imprimis NJOF of Ledgewood, New Jersey, NDC 71384-641-01, is being recalled. The action covers 6,880 vials.

The stated reason is a sub-potent drug: subpotent assay results during stability testing. The FDA classified the action as Class II.

The affected lot is 24DEC017, expiring 07/12/2025. Distribution was nationwide in the USA. The vials are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the NDC and lot number above and follow the instructions issued by the compounder.

The recalled product

Product
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
Manufacturer
Imprimis NJOF, LLC
Category
Drug — Compounded injectable
Hazard
Affected units
6,880

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 24DEC017
  • Exp. 07/12/2025.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Imprimis NJOF, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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