FDA Drugs recall ·
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets… recall
- Recall number
- D-0255-2026
- Date
- (initiated December 16, 2025)
- Company / brand
- SpecGx, LLC
385 Marshall Ave, Webster Groves, MO, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 74,544 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 0522J23493, expires: 03/2027.
Distribution
Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0255-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.