ENDO USA, Inc.: Drug Recall
Recall #D-0223-2025 · 12/20/2024
Class I: Dangerous
Recall Details
- Recall Number
- D-0223-2025
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- ENDO USA, Inc.
- Status
- Ongoing
- Date Initiated
- 12/20/2024
- Location
- Rochester, MI, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44,397 amber glass vials
Reason for Recall
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Product Description
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
Distribution Pattern
USA nationwide.
Other Recalls by ENDO USA, Inc.
- Class III: Low Risk 10/10/2025
- Class III: Low Risk 10/10/2025
- Class III: Low Risk 10/10/2025
- Class III: Low Risk 10/10/2025
- Class III: Low Risk 09/05/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.