Recalls / Class I
Class ID-0223-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- All lots within expiry
Why it was recalled
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Recalling firm
- Firm
- ENDO USA, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 870 Parkdale Rd, Rochester, Michigan 48307-1740
Distribution
- Quantity
- 44,397 amber glass vials
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-12-20
- FDA classified
- 2025-02-05
- Posted by FDA
- 2025-02-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0223-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.