FDA recall D-0255-2026

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

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

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