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Class II: temporary or reversible health riskOngoing

SpecGx Oxycodone and Acetaminophen CII Tablets Recall

Oxycodone and Acetaminophen CII Tablets USP, 7

SpecGx, LLC · Webster Groves, MO

Risk level
Class II
Reported by FDA
Jan 14, 2026
Recall ID
D-0255-2026
Check your lot numberHow we source this data

Summary

SpecGx recalled Oxycodone and Acetaminophen CII Tablets starting Dec 16, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0255-2026 on Jan 14, 2026. Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. Status: Ongoing.

Why it was recalled

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

Lot numbers, UPCs & expiration codes

Lot: 0522J23493, expires: 03/2027.

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0255-2026
Classification
Class II
Status
Ongoing
Recall initiated
Dec 16, 2025
FDA report date
Jan 14, 2026
Quantity
74,544 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
SpecGx, LLC

Original FDA data

Every field from FDA enforcement report D-0255-2026, exactly as published.

Show all FDA fields
City
Webster Groves
State
MO
Status
Ongoing
Country
United States
Event ID
98136
Address
385 Marshall Ave
Code information
Lot: 0522J23493, expires: 03/2027.
Postal code
63119-1831
Report date
Jan 14, 2026
Product type
Drugs
Recall number
D-0255-2026
Classification
Class II
Recalling firm
SpecGx, LLC
Product quantity
74,544 bottles
Reason for recall
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Dec 16, 2025
Initial firm notification
E-Mail
Center classification date
Jan 7, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0255-2026, published Jan 14, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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