Oxycodone and acetaminophen tablets recalled for missing imprint
SpecGx LLC is recalling 287,988 bottles of oxycodone and acetaminophen combination tablets due to a potential for missing imprints on some tablets. Affected lot numbers expire from May to June 2027.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of oxycodone tablets with a potential for missing imprints. While no illnesses or injuries have been reported, the missing identification marking is a labeling defect. In the context of prescription medications where pharmacy dispensing provides a primary label, this constitutes a minor labeling error meeting severity level 2 (Moderate).
Plain-English summary
SpecGx LLC is recalling oxycodone and acetaminophen combination tablets (10 mg/325 mg) due to a potential for missing imprints on some tablets. Approximately 287,988 bottles are affected by this nationwide recall. The affected lot numbers are 0523J23904 (expires May 2027), 0523J24426, and 0523J24427 (expires June 2027).
The missing imprint on tablets prevents visual identification of the medication. The imprint is an important identifier that patients and healthcare providers use to verify the prescription.
Consumers should check their medication bottles to determine if they have an affected lot number. Patients should not use tablets without visible imprints and should contact their pharmacist.
Patients with affected medication should return it to their pharmacy for replacement or refund.
The recalled product
- Product
- OXYCODONE AND ACETAMINOPHEN (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN)
- Brand
- OXYCODONE AND ACETAMINOPHEN
- Manufacturer
- SpecGx, LLC
- Category
- Drug
- Hazard
- missing-imprint
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot: 0523J23904
- expires: 05/2027
- 0523J24426
- 0523J24427
- expires: 06/2027.
UPCs (3)
- 0304060522053
- 0304060523050
- 0304060512054
Distribution
Distributed nationwide across the United States.
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