Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96947

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

Open FDA event record

Event summary

Timeline bucket
May 28, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Pfizer Inc.

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

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

DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62

D-0489-2025
Recall number
D-0489-2025
Initiated
May 28, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Pfizer Inc.
Quantity
98,410 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Discoloration; discolored solution from cracked vials

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration; discolored solution from cracked vials

Code information

Lot KA5023, exp 02/28/2026

Distribution pattern

Nationwide in the USA