May 2026 FDA Recall Epinephrine by Fresenius Kabi Usa, Llc
D-0581-2026 - Failed Impurities/Degradations Specifications
This Class III drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on May 14, 2026 for the product Epinephrine. The FDA reported the reason for recall as failed impurities/degradations specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0581-2026
Failed Impurities/Degradations Specifications
05-14-2026
06-17-2026
898,050 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Kabi USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Batch or Lot Expiration Information
Batch# 6133313, 6133314, Exp Date: 06/2026
Batch# 6133315, Exp Date: 07/2026
Batch# 6133682, Exp Date: 09/2026
Batch# 6134812, 6134813, Exp Date: 04/2027.
