SpecGx Initiates Class II Recall of Oxycodone/Acetaminophen Tablets Over Missing Imprint Risk
Key Takeaways
- SpecGx, LLC has initiated a voluntary nationwide Class II recall of oxycodone and acetaminophen tablets due to a tablet imprint issue.
- Nearly 288 000 bottles across multiple lots are affected, with distribution to pharmacies nationwide.
- Missing tablet imprints may increase the risk of medication identification errors, particularly for controlled substances.
SpecGx, LLC is recalling Oxycodone and Acetaminophen CII Tablets USP, 10 mg/325 mg, packaged in bottles of 100 tablets and labeled with NDC 0406-0523-01. The affected lots include 0523J23904 (expiration May 2027) and 0523J24426 and 0523J24427 (expiration June 2027). In total, 287 988 bottles of the prescription-only product were distributed nationwide. The recall, identified as D-0254-2026 under US Food and Drug Administration (FDA) Event ID 98136, remains ongoing.
The FDA has classified this action as a Class II recall, indicating that exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health outcomes is remote. The recall was voluntarily initiated by the firm on December 16, 2025, with the FDA assigning the classification on January 7, 2026. Notifications to consignees were issued via email, and no public press release has been issued at this time.
According to the FDA Enforcement Report, the reason for the recall is a failure to meet tablet specification requirements, specifically a potential for the imprint to be missing on tablets. For pharmacists and other healthcare professionals, tablet imprints are a critical safety feature used to verify drug identity, strength, and manufacturer. Missing imprints on a Schedule II controlled substance such as oxycodone increase the risk of dispensing errors, misuse, or difficulty in identifying tablets during medication reconciliation or in cases of diversion or overdose.
Oxycodone and acetaminophen combination tablets are indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate and alternative treatments are inadequate. Oxycodone provides opioid analgesia, while acetaminophen enhances pain relief through non-opioid mechanisms.
Reference
FDA. Enforcement Report. January 14, 2026. Accessed January 15, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm
