🚨 American Regent Recalls Epinephrine Injection – September 2026
American Regent, Inc. has announced a voluntary nationwide recall in the United States involving three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multiple-dose vials.
📌 Recall Details
- 🏢 Company: American Regent, Inc.
- 💉 Product: Epinephrine Injection, USP
- 💊 Strength: 1 mg/mL
- 📦 Package: 30 mL multiple-dose vial
- 🇺🇸 Market: United States
- 📅 Recall announced: September 3, 2026
- 🔢 NDC: 0517-3030-01
❌ Recalled Lots
| Lot No. | Expiry | Distribution Period |
|---|---|---|
| 25128L1C0 | August 2026 | Sep. 4, 2025 – Dec. 18, 2025 |
| 25280L1C0 | October 2026 | Dec. 16, 2025 – Apr. 17, 2026 |
| 26108L1C0 | July 2027 | Jun. 15, 2026 – Jul. 31, 2026 |
All three lots were distributed nationwide across the United States.
⚠️ Why Was It Recalled?
The recall followed complaints concerning leaking and cracked vials. The company’s investigation also identified particulate matter, including:
- Nylon
- Cellulosic material
- Acrylic
- Polyethylene
- Glass
Damaged vials may compromise sterility and product integrity, while particulate contamination can create additional risks, particularly when the product is administered intravenously.
🩺 Potential Health Risks
According to the recall information, injection of particulate-containing epinephrine into the bloodstream could potentially cause:
- Blood-vessel blockage
- Clotting
- Reduced blood flow to vital organs
- Pulmonary embolism
- Permanent organ damage
- Death
- Local vein irritation
- Inflammatory reactions
- Allergic reactions
American Regent stated that no adverse events associated with the recalled products had been reported as of the recall announcement.
💉 Product Uses
Epinephrine Injection is used under the direction of healthcare professionals for:
- Emergency treatment of Type I allergic reactions, including anaphylaxis
- Increasing mean arterial blood pressure in adults with hypotension associated with septic shock
🏥 What Should Healthcare Facilities Do?
Distributors, retailers and healthcare facilities possessing the affected lots should:
- Stop using the recalled lots.
- Separate the affected products from usable inventory.
- Return them to the place of purchase or follow the manufacturer’s disposal instructions.
- Contact American Regent regarding return, replacement and credit arrangements.
⚠️ Important: This recall applies specifically to the listed lot numbers. Healthcare facilities should check the lot number and NDC on their inventory rather than assuming every epinephrine product is affected.
The recall is being conducted with the knowledge of the U.S. FDA.
