HIGHFDA DRUG

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)

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
May 14, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
May 14, 2026
Hazard Level
HIGH
Brands
EPINEPHRINE, Fresenius Kabi USA, LLC
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
EPINEPHRINE, Fresenius Kabi USA, LLC
Model numbers
Batch # 6133313, 6133314, Exp Date: 06/2026, Batch # 6133315, Exp Date: 07/2026, Batch # 6133682, Exp Date: 09/2026, Batch # 6134812 +2 more
UPC codes
63323-696, 63323-696-02, 63323-696-25
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    May 14, 2026

  2. Reported by FDA DRUG

    June 17, 2026

  3. RecallRadar source check

    June 23, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Failed Impurities/Degradations Specifications

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter

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Full 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). Generic: EPINEPHRINE; Brand: EPINEPHRINE. Reason: Failed Impurities/Degradations Specifications. Classification: Class III. Quantity: 898,050 vials. Distribution: US Nationwide.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Batch # 6133313
6133314
Exp Date: 06/2026
Batch # 6133315
Exp Date: 07/2026
+5 more
UPC Codes
63323-696
63323-696-02
63323-696-25
Affected States
ALL
Report Date
June 17, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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