RECALL DATABASE

Oxycodone and Acetaminophen Recall: SpecGx 7.5/325

Announced 2026-01-14 · FDA

The recall covers SpecGx LLC Oxycodone and Acetaminophen CII tablets, 7.5 mg/325 mg, Rx only, in 100-count bottles (NDC 0406-0522-01), Lot 0522J23493, Exp 03/2027, distributed nationwide, affecting 74,544 bottles. The recall is due to a potential for the imprint to be missing on tablets.

BrandSpecGx, LLC
ProductOxycodone 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
ReasonFailed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Severitymoderate
Units affected287988
DistributionNationwide
AgencyFDA
Recall / campaign no.Lot: 0522J23493, expires: 03/2027.

WHAT YOU SHOULD DO

  1. Do not take or use this medication.
  2. Check your bottle for Lot 0522J23493 and expiration 03/2027; if matched, set aside and do not consume.
  3. Contact your pharmacist or healthcare provider for guidance and possible replacement.
  4. Follow local disposal instructions for recalled medicines.

This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.