Exact FDA event identifier

Event 93254

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

Event summary

Timeline bucket: October 20, 2023
Product types: Drug
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Zyla Life Sciences US 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

Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11

D-0094-2024

Recall number: D-0094-2024
Initiated: October 20, 2023
Classification: Class III
Status: Ongoing
Recalling firm: Zyla Life Sciences US Inc.
Quantity: 3,792 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Sub-potent Drug: Lower potency than labeled.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Sub-potent Drug: Lower potency than labeled.

Code information

Lot 22W02, Exp 01/31/2025

Distribution pattern

Nationwide