FDA-Drug2026-01-14Class IIPACKAGING DEFECT
SpecGx oxycodone and acetaminophen tablets recalled for missing imprint
What this means
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.
- Check if your bottle matches: NDC 0406-0522-01, Lot 0522J23493, expires 03/2027
- Look at your tablets to see if the imprint is missing
- Contact your pharmacy or prescriber if you have this lot
- Do not stop taking your medication without talking to your doctor first
The agency's original wording
Hazard
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide
Affected count
74,544 bottles
Manufactured in
385 Marshall Ave, Webster Groves, MO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0255-2026Want us to check the next one for you?
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