Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119,
Summary
The FDA issued a Class II for Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only by SpecGx, LLC. Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets..
Details
Source
Drug Recall
External ID
D-0255-2026
Action Date
2026-01-14
Status
Ongoing
Category
drug
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/Code Info: Lot: 0522J23493, expires: 03/2027.
Quantity Affected: 74,544 bottles
Reason for Recall
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-16
Company
Webster Groves, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SpecGx, LLC has 19 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SpecGx, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SpecGx, LLC have FDA actions?
SpecGx, LLC has 19 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0255-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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