Epinephrine Injection, Solution, Concentrate
FDA Recall NDC 63323-696
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Epinephrine (NDC 63323-696). A significant event, classified as Class III, was initiated on May 14, 2026 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Failed Impurities/Degradations Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Impurities/Degradations Specifications
May 14, 2026
Jun 17, 2026
898,050 vials
Recall Profile & Regulatory Data
Event ID
98997
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
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.
Affected Packages Involved in this Recall
63323-696-02Product
63323-696-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
