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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98883

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

Open FDA event record

Event summary

Timeline bucket
May 04, 2026
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Sagent Pharmaceuticals

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

Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.

D-0539-2026
Recall number
D-0539-2026
Initiated
May 04, 2026
Classification
Class III
Status
Ongoing
Recalling firm
Sagent Pharmaceuticals
Quantity
Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications

Code information

Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.

Distribution pattern

Nationwide within the United States