Moderate riskFDA DrugClass II

SpecGx oxycodone and acetaminophen tablets recalled for missing imprint

SpecGx LLC is recalling one lot of oxycodone and acetaminophen tablets (7.5 mg/325 mg) because some tablets may be missing the imprint (identifying mark). This makes it difficult to verify you have the correct medication. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if your bottle matches: NDC 0406-0522-01, Lot 0522J23493, expires 03/2027
  2. Look at your tablets to see if the imprint is missing
  3. Contact your pharmacy or prescriber if you have this lot
  4. Do not stop taking your medication without talking to your doctor first

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected
74,544 bottles
Illnesses reported
None reported
Manufactured in
385 Marshall Ave, Webster Groves, MO, United States
Classification
Class II
Recall number
D-0255-2026

In the FDA's words

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 Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. Lot: 0522J23493, expires: 03/2027. Distribution: Nationwide Affected quantity: 74,544 bottles
Hazard
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

2 products in this recall

The agency lists each product separately. Check every one you might have.

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