EPINEPHRINE Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx O Recall 2026
EPINEPHRINEIssued August 11, 2026
EPINEPHRINE Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-303 — recalled per FDA on 8/11/2026. Reason: Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials..
What to do about this recall
- Agency
- FDA
- Issued
- Aug 11, 2026
- Brand
- EPINEPHRINE
- Distribution
- 1 states
- Lots affected
- 9
Steps to take for this recall
Stop using it
Take it out of rotation. Don't consume, wear, or operate.
Verify the match
Compare lot numbers, UPCs, and dates against your product.
Return or dispose
Follow the manufacturer's instructions to refund or safely dispose.
What's recalled
Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01
Why it was recalled
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Affected products & lot numbers9 lots called out
Affected Lot Numbers
Check your product label — do not use if your lot number appears below.
| Lot Number |
|---|
| Lots: 25128L1C0 |
| Exp. August 31 |
| 2026 |
| 25280L1C0 |
| Exp. October 31 |
| 2026 |
| 26108L1C0 |
| Exp. July 31 |
| 2027 |
Where was it sold1 state
Nationwide within the U.S.A
More recalls like this4 related — by brand, contaminant, and category
Recent Medications recalls
- Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, Recall 20262026
- NYSTATIN Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Indust Recall 20262026
- DOPAMINE HYDROCHLORIDE Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per t Recall 20262026
Frequently asked questions
Is the EPINEPHRINE recall still active?
Yes, this recall is currently active as of August 11, 2026. Do not use or consume the affected product.
What lot numbers are affected?
Affected lot numbers: Lots: 25128L1C0, Exp. August 31, 2026, 25280L1C0, Exp. October 31, 2026, 26108L1C0, Exp. July 31, 2027. Check the label on your product.
What should I do if I have the recalled EPINEPHRINE?
Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.