Medications & Supplements/Prescription Drugs

SpecGx Oxycodone and Acetaminophen Tablets Recalled for Missing Imprints

Agency Publication Date: January 7, 2026

Summary

SpecGx, LLC is recalling 362,532 bottles of Oxycodone and Acetaminophen CII Tablets (USP) because some tablets may be missing their required identification imprint. This recall includes 10mg/325mg and 7.5mg/325mg strengths sold in 100-count bottles nationwide. If a tablet lacks the correct imprint, patients or caregivers may be unable to verify the medication's identity and strength, which is critical for this controlled substance.

Risk

The missing imprint prevents the proper identification of the medication, which could lead to accidental ingestion of the wrong dose or the wrong drug entirely. For a potent opioid medication like Oxycodone, taking an incorrect dose or drug can lead to serious adverse health consequences, including respiratory depression or overdose.

What You Should Do

Check your medication bottles for Oxycodone and Acetaminophen CII Tablets USP with NDC codes 0406-0523-01 (10mg/325mg) or 0406-0522-01 (7.5mg/325mg).
For the 10mg/325mg strength (NDC 0406-0523-01), check for lot numbers 0523J23904 (Exp 05/2027), 0523J24426 (Exp 06/2027), or 0523J24427 (Exp 06/2027).
For the 7.5mg/325mg strength (NDC 0406-0522-01), check for lot number 0522J23493 with an expiration date of 03/2027.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg (100 tablets)

Variants: 10mg/325 mg, Tablet

Lot Numbers:

0523J23904 (Exp 05/2027)

0523J24426 (Exp 06/2027)

0523J24427 (Exp 06/2027)

NDC:

0406-0523-01

Rx only; Recall #: D-0254-2026; Quantity: 287,988 Bottles.

Product: Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg (100 tablets)

Variants: 7.5 mg/325 mg, Tablet

Lot Numbers:

0522J23493 (Exp 03/2027)

NDC:

0406-0522-01

Rx only; Recall #: D-0255-2026; Quantity: 74,544 bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98136

Status: Active

Manufacturer: SpecGx, LLC

Sold By: Retail Pharmacies

Manufactured In: United States

Units Affected: 2 products (287,988 Bottles.; 74,544 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medication bottles for Oxycodone and Acetaminophen CII Tablets USP with NDC codes 0406-0523-01 (10mg/325mg) or 0406-0522-01 (7.5mg/325mg).

For the 10mg/325mg strength (NDC 0406-0523-01), check for lot numbers 0523J23904 (Exp 05/2027), 0523J24426 (Exp 06/2027), or 0523J24427 (Exp 06/2027).

For the 7.5mg/325mg strength (NDC 0406-0522-01), check for lot number 0522J23493 with an expiration date of 03/2027.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg (100 tablets)

Variants: 10mg/325 mg, Tablet

Lot Numbers:

0523J23904 (Exp 05/2027)

0523J24426 (Exp 06/2027)

0523J24427 (Exp 06/2027)

NDC:

0406-0523-01

Rx only; Recall #: D-0254-2026; Quantity: 287,988 Bottles.

Product: Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg (100 tablets)

Variants: 7.5 mg/325 mg, Tablet

Lot Numbers:

0522J23493 (Exp 03/2027)

NDC:

0406-0522-01

Rx only; Recall #: D-0255-2026; Quantity: 74,544 bottles.