Unrated Drug recall · FDA · Published May 14, 2026

Fresenius Kabi Epinephrine Injection Recall: Failed Impurities May Cause Harm

Fresenius Kabi recalls specific batches of Epinephrine Injection due to failed impurities and degradations. Affected units may pose health risks if used improperly. Contact for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0581-2026Drug Fresenius Kabi ›

Recall notice

Failed Impurities/Degradations Specifications

Take action

Contact the company

Recalling firmFresenius Kabi USA, LLC3 Corporate Dr · Lake Zurich, IL 60047-8930

✎ GovInfoNow plain-language explainer

Fresenius Kabi is recalling certain batches of Epinephrine Injection vials because they may contain impurities or degradations that could cause harm. This is a serious issue for people who need this medication in emergencies. Read more at govinfonow.com/recall/31308-fresenius-kabi-epinephrine-injection-recall-failed-impurities-may-cause-harm.

Source Summary by GovInfoNow · govinfonow.com/recall/31308-fresenius-kabi-epinephrine-injection-recall-failed-impurities-may-cause-harm · Updated August 17, 2026 · FDA enforcement record: FDA #D-0581-2026

Cite this page

“Fresenius Kabi Epinephrine Injection Recall: Failed Impurities May Cause Harm.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31308-fresenius-kabi-epinephrine-injection-recall-failed-impurities-may-cause-harm. Based on FDA recall #D-0581-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0581-2026%22&limit=1).

The FDA announced on May 14, 2026, that Fresenius Kabi USA, LLC is recalling Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vials due to failed impurities and degradations specifications. The voluntary Class III recall affects 898,050 units distributed nationwide.

How to tell if you have it

Brand: Fresenius Kabi
Product: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial
NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
Batch # 6133313, Exp Date: 06/2026
Batch # 6133314, Exp Date: 06/2026
Batch # 6133315, Exp Date: 07/2026
Batch # 6133682, Exp Date: 09/2026
Batch # 6134812, Exp Date: 04/2027
Batch # 6134813, Exp Date: 04/2027

The hazard

The recall is due to failed impurities and degradations specifications. The FDA reported no specific incidents or injuries associated with this recall in the provided record.

Context

GovInfoNow's records show Fresenius Kabi USA, LLC has 65 other recalls on record since 2012-09-27. Other recent recalls of similar products include Fresenius Kabi Tyenne Injection Recall (2026-08-10), Fresen: Morphine Syringes May Have Wrong Labeling (2026-08-04), and Fresenius Kabi Lidocaine HCl Injection Recall (2026-07-16). Other recent recalls of similar products include Fresenius Kabi Ketamine HCl Injection Recall (2026-02-05), American Regent Epinephrine Injection Recall (2026-08-11), and EPINEPHR: Sterility Risk in 1 mg/10mL Injection Recall (2026-04-01).

How to tell if you have this one

Check the NDC numbers: 63323-696-02 (vial) or 63323-696-25 (carton). Look for batch numbers 6133313, 6133314, 6133315, 6133682, 6134812, or 6134813 with expiration dates up to 09/2026.

Brand
Fresenius Kabi
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the NDC numbers and batch numbers listed in the recall notice to confirm if your vial is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 34 days after the firm started it.

May 14, 2026Firm started the recall
Jun 5, 2026FDA classified it Class III
Jun 17, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31308-fresenius-kabi-epinephrine-injection-recall-failed-impurities-may-cause-harm">Fresenius Kabi Epinephrine Injection Recall: Failed Impurities May Cause Harm (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0581-2026 (May 14, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0581-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.