The National Agency for Food and Drug Administration and Control (NAFDAC) has issued an alert regarding counterfeit Oxycontin 80mg (oxycodone hydrochloride) detected in Switzerland’s unregulated market. The warning, detailed in public alert No. 07/2025, was published on NAFDAC’s website on Thursday, March 20, 2025.
The falsified product came to light in February when MUNDIPHARMA, the legitimate manufacturer, reported it to the World Health Organization (WHO). This counterfeit mimics the authentic OXYCONTIN 80mg, a semi-synthetic opioid approved in Poland for managing moderate to severe pain. However, lab analysis by the Drug Information Centre (DIZ) in Zurich revealed that the fake tablets contain no oxycodone. Instead, they harbor a potent synthetic opioid, likely a nitazene compound.
NAFDAC explained that nitazene derivatives—such as metonitazene, isotonitazene, and fluonitazene—are powerful research chemicals with extreme addiction potential and severe side effects. These substances can be hundreds of times stronger than oxycodone, drastically increasing the risk of overdose. The agency emphasized the limited data on their toxicity, risks, and long-term effects, making them especially hazardous.
The agency stated, “The identified product in this alert is confirmed as falsified on the basis that it deliberately/fraudulently misrepresented its identity, composition, or source. The falsified product imitates OXYCONTIN 80mg manufactured and marketed by MUNDIPHARMA in the Polish market. MUNDIPHARMA has confirmed that the product was falsified and was not produced by their company.”
Further, NAFDAC warned, “This falsified product has been found to contain undeclared nitazene compounds, which pose a significant risk due to the high likelihood of adverse events, even in small doses. Nitazenes produce similar effects to other opioids. Their high potency carries a high risk of overdose and death. Using nitazene derivatives has been linked to several deaths. Mixing them with other depressants like alcohol or benzodiazepines can be very dangerous, leading to severe effects like respiratory depression, low blood pressure, coma, or even death.”
The counterfeit poses a unique threat to individuals with substance use disorders, who may mistake it for a legitimate, quality-assured medicine. Visual clues to identify the fake include misplaced batch and expiration dates. On the falsified product, these appear on the front of the blister strip, with the expiration date on the left and batch number on the right. In contrast, genuine OXYCONTIN displays them on the back, with the batch number on the left and expiration date on the right.
NAFDAC has directed its zonal directors and state coordinators in Nigeria to monitor and remove any of these falsified products from circulation. The agency urged importers, distributors, retailers, healthcare providers, and consumers to remain vigilant and avoid handling or using these counterfeit tablets. It stressed, “All medical products/medical devices must be obtained from authorised/licensed suppliers,” and advised thorough checks of product authenticity and condition.
Healthcare professionals and the public are encouraged to report suspicions of substandard or falsified medicines to NAFDAC’s nearest office, via the toll-free number 0800-162-3322, or email sf.alert@nafdac.gov.ng.
