Exact FDA event identifier

Event 98997

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 14, 2026
Product types: Drug
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Fresenius Kabi USA, LLC

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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)

D-0581-2026

Recall number: D-0581-2026
Initiated: May 14, 2026
Classification: Class III
Status: Ongoing
Recalling firm: Fresenius Kabi USA, LLC
Quantity: 898,050 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Impurities/Degradations Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradations Specifications

Code information

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.

Distribution pattern

US Nationwide.