# FDA recall D-0535-2025

> **Imprimis NJOF, LLC** · Class II · drug recall initiated 2025-07-09.

## 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

## Reason for recall

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

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0535-2025
- **Recalling firm:** Imprimis NJOF, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2025-07-09
- **Report date:** 2025-07-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ledgewood, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0535-2025

## Citation

> AI Analytics. FDA recall D-0535-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0535-2025. Source: US FDA. Licensed CC0.

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