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Epinephrine Injection 1mg/mL
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DRUG RECALLLOW

Epinephrine Injection 1mg/mL

Fresenius Kabi is recalling Epinephrine Injection 1mg/mL vials due to out-of-specification stability test results.

What to do

Healthcare providers should immediately examine their inventory, quarantine any affected product, and contact the manufacturer for return instructions.

Recalled
Listed
Updated
Recall No.
D-0581-2026
Agency
FDA
Firm
Fresenius Kabi USA, LLC
Recall ID
98997
Status
ONGOING

Recall at a glance

Quantity recalled
898,050 vials

Why it was recalled

Fresenius Kabi is recalling specific lots of Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vials due to out-of-specification results during stability testing, indicating potential degradation of the product.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Epinephrine Injection, USP

Lot code
6133313, 6133314, 2026, 6133315, 6133682, 6134812, 6134813, 2027
Strength
1 mg
NDC / UPC
NDC 63323-696-02, NDC 63323-696-25

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other recent recalls from Fresenius Kabi USA, LLC

All recalls from Fresenius Kabi USA, LLC

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Editorial summary by Recall Canary · summary updated 2026-06-06 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification