# FDA recall D-0223-2025

> **ENDO USA, Inc.** · Class I · drug recall initiated 2024-12-20.

## Product

Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-103-01

## Reason for recall

Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-0223-2025
- **Recalling firm:** ENDO USA, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-12-20
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0223-2025

## Citation

> AI Analytics. FDA recall D-0223-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0223-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*