FDA Drugs recall ·
Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP)… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0223-2025
- Date
- (initiated December 20, 2024)
- Company / brand
- Endo USA, Inc.
870 Parkdale Rd, Rochester, MI, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 44,397 amber glass vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots within expiry
Distribution
USA nationwide.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0223-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.