Fresenius Kabi Epinephrine Injection Recall
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Fresenius Kabi USA is recalling 898,050 vials of Epinephrine Injection due to failed impurities and degradations specifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 27, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.
What Happened
Fresenius Kabi USA, LLC initiated a voluntary recall of Epinephrine Injection, USP after the products failed impurities and degradations specifications.
Which Products Are Affected
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). Affected batches: 6133313, 6133314 (Exp 06/2026); 6133315 (Exp 07/2026); 6133682 (Exp 09/2026); 6134812, 6134813 (Exp 04/2027). Total of 898,050 vials distributed nationwide.
What You Should Do
Consumers should contact their healthcare provider or pharmacist regarding affected product.
Why This Matters
This Class III recall affects nearly 900,000 vials of a prescription drug distributed across the United States.
Source
FDA Recall D-0581-2026 - Fresenius Kabi USA, LLC
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (867 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to July 27, 2026.
Frequently Asked Questions
Common questions about this FDA recall.