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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98136

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 16, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
SpecGx, LLC

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

2 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 2

Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.

D-0254-2026
Recall number
D-0254-2026
Initiated
December 16, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SpecGx, LLC
Quantity
287,988 Bottles.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Code information

Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.

Distribution pattern

Nationwide

drug · product 2 of 2

Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493

D-0255-2026
Recall number
D-0255-2026
Initiated
December 16, 2025
Classification
Class II
Status
Ongoing
Recalling firm
SpecGx, LLC
Quantity
74,544 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Code information

Lot: 0522J23493, expires: 03/2027.

Distribution pattern

Nationwide