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Recall Observatory FDA recall evidence

Drug 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)

D-0581-2026

May 14, 2026

Class III

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 98997
Status
Ongoing
Classification
Class III
Quantity
898,050 vials
Official record key
drug-enforcement:D-0581-2026

Official wording

Reason: Failed Impurities/Degradations Specifications

Code 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.

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Impurities/Degradations Specifications