The FDA reported that Fresenius Kabi USA recalled 898,050 vials of Epinephrine Injection, USP (1 mg/mL, 1 mL single-dose vials) on May 14, 2026 after 18-month stability tests produced out-of-specification impurity or degradation results. Affected NDCs are 63323-696-02 and 63323-696-25, with specific batch numbers and expiration dates listed by the agency. The recall is Class III, meaning regulators do not expect direct harm, but reduced potency could leave a dose less effective during an emergency. Patients with matching vials should contact their prescriber or pharmacy to arrange a replacement.
Nearly 900,000 Epinephrine Vials Recalled Nationwide Over Stability Test Failures
US Food and Drug Administration (FDA) website detailMarioGuti/Getty Images(MarioGuti/Getty Images)
Caregivers and patients who rely on epinephrine for severe allergic reactions — including anaphylaxis from food or insect stings — as well as for some cases of severe asthma, certain cardiac conditions, or low blood pressure should check their supplies after a major recall.
What happened: According to an FDA report published June 6, 2026, Fresenius Kabi USA, LLC initiated a nationwide recall on May 14 of 898,050 vials of epinephrine after 18-month stability testing produced out-of-specification results. The agency described the issue as Failed Impurities/Degradations Specifications; out-of-specification (OOS) results obtained at the 18-month stability test. That finding could indicate the active ingredient’s potency declines during storage, which might result in a vial not delivering the full labeled amount.
Recalled Product Details
Product: Epinephrine Injection, USP, 1 mg/mL
1 mL single-dose vial, Rx only
NDCs: 63323-696-02 (vial); 63323-696-25 (carton)
Affected Batch Numbers and Expiration Dates:
- Batch 6133313 — Expiration 06/2026
- Batch 6133314 — Expiration 06/2026
- Batch 6133315 — Expiration 07/2026
- Batch 6133682 — Expiration 09/2026
- Batch 6134812 — Expiration 04/2027
- Batch 6134813 — Expiration 04/2027
What The FDA Says: The recall was classified as Class III, meaning the agency considers exposure to the recalled product not likely to cause adverse health consequences. However, regulators and clinicians warn that a loss of potency could make a dose less effective in a life-threatening emergency.
What Patients Should Do
- Check your epinephrine vials now for matching NDC, batch number, and expiration date.
- If you have an affected vial, contact your prescribing clinician or pharmacy immediately to request a replacement. Do not assume an alternative vial is equivalent without professional guidance.
- Contact Fresenius Kabi USA or the pharmacy for additional recall instructions if needed, and follow any disposal guidance provided by health professionals or local regulations.
- Keep an accessible, unexpired emergency dose on hand — discuss replacement options with your clinician if your supply is affected.
This action follows a similar April 2026 recall that removed about 81,000 epinephrine products for related stability concerns. For specific questions about the recall or whether your product is included, reach out to your pharmacist, prescriber, or the manufacturer.
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