The Recall Registry
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Home Prescription medicine Fresenius Kabi USA, LLC — Epinephrine…

Food & drug recall · FDAMay 14, 2026Labelling issue

Fresenius Kabi USA, LLC — 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)

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Failed Impurities/Degradations Specifications

The Recall Registry rates this labelling issueFDA Class III: unlikely to cause harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Fresenius Kabi USA, LLC

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)

Details

Units affected
898,050 vials
Recall date
May 14, 2026
Brand
Fresenius Kabi USA, LLC
Model, lot or SKU numbers
Batch # 6133313, 6133314, Exp Date: 06/2026Batch # 6133315, Exp Date: 07/2026Batch # 6133682, Exp Date: 09/2026Batch # 6134812, 6134813, Exp Date: 04/2027.
Where it was distributed

US Nationwide

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: Fresenius Kabi USA, LLC — 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)

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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