SpecGx LLC recalled 287,988 bottles of Oxycodone and Acetaminophen tablets on December 16, 2025. The tablets may lack proper imprinting, posing risks for misuse and confusion. Healthcare providers and consumers must stop using the product immediately and seek guidance.
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Consumers and healthcare providers should stop using this product immediately. Contact SpecGx, LLC or your healthcare provider for guidance. Notification method: E-Mail
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The recalled product is Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, packaged in bottles of 100 tablets. The affected lot numbers include 0523J23904, 0523J24426, and 0523J24427, with expiration dates ranging from May 2027 to June 2027. The product was distributed nationwide.
The recall is due to a potential lack of imprint on the tablets, which can lead to confusion in identifying the medication. This poses a serious risk as it may lead to accidental overdose or misuse, especially if patients are unaware of the missing imprint.
No specific injuries or incidents have been reported related to this recall. However, the potential for misuse due to the missing imprint raises significant safety concerns.
Consumers and healthcare providers should stop using the recalled product immediately. Contact SpecGx, LLC or your healthcare provider for further guidance and potential refund processes.
For more information, consumers can reach SpecGx, LLC through email as specified in the recall notice. Additional details are available at the FDA website link provided in the recall announcement.
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