Why it was recalled
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
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0223-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Dec 20, 2024
- FDA report date
- Feb 12, 2025
- Quantity
- 44,397 amber glass vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ENDO USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0223-2025, exactly as published.
Show all FDA fields
- City
- Rochester
- State
- MI
- Status
- Ongoing
- Country
- United States
- Event ID
- 96013
- Address
- 870 Parkdale Rd
- Code information
- All lots within expiry
- Postal code
- 48307-1740
- Report date
- Feb 12, 2025
- Product type
- Drugs
- Recall number
- D-0223-2025
- Classification
- Class I
- Recalling firm
- ENDO USA, Inc.
- 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)
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Recall initiation date
- Dec 20, 2024
- Initial firm notification
- Press Release
- Center classification date
- Feb 5, 2025