← FDA ENFORCEMENT
D-0255-2026Class II

SpecGx, LLC

Recalling firm
SpecGx, LLC
Product type
Drug
Status
Ongoing
Report date
2026-01-14
Distribution
Nationwide
Firm state
MO
Product quantity
74,544 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

Lot: 0522J23493, expires: 03/2027.

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.