Exact FDA event identifier

Event 99131

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

Event summary

Timeline bucket: June 02, 2026
Product types: Drug
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: ANI Pharmaceuticals, 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

hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10

D-0619-2026

Recall number: D-0619-2026
Initiated: June 02, 2026
Classification: Class III
Status: Ongoing
Recalling firm: ANI Pharmaceuticals, Inc.
Quantity: 6564 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

foreign substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of foreign substance

Code information

Lot S25133A

Distribution pattern

Nationwide in the USA