Recall: D-0255-2026

Class II - Potentially Harmful

Class IIClassification

2025-12-16Initiated

OngoingStatus

SpecGx, LLCFirm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.