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Fresenius Kabi Usa, LLC

Low risk

The FDA considers this unlikely to cause harm. Return it for a refund if you would rather not keep it.

Class III

  • Unlikely to cause any adverse health consequence, but the product breaks FDA rules.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Low risk Filed 2026-06-17

Failed Impurities/Degradations Specifications

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)

Check these codes: 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.

898,050 vials · distributed us nationwide. Recall D-0581-2026 on FDA.gov ↗
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