Exact FDA event identifier

Event 98610

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

Event summary

Timeline bucket: March 13, 2026
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: ENDO USA, 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

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

Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.

D-0527-2026

Recall number: D-0527-2026
Initiated: March 13, 2026
Classification: Class II
Status: Ongoing
Recalling firm: ENDO USA, Inc.
Quantity: 34,293 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Crystallization; identified as Buprenorphine free base

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization; identified as Buprenorphine free base

Code information

Lot #: 84132, Exp 02/28/2027; 87693, Exp 03/31/2027

Distribution pattern

USA Nationwide