# FDA recall D-0255-2026

> **SpecGx, LLC** · Class II · drug recall initiated 2025-12-16.

## Product

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

## Reason for recall

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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0255-2026
- **Recalling firm:** SpecGx, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-12-16
- **Report date:** 2026-01-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Webster Groves, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0255-2026

## Citation

> AI Analytics. FDA recall D-0255-2026. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0255-2026. Source: US FDA. Licensed CC0.

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