Cofepris Warns of Counterfeit Ozempic Sold in Mexico

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Mexico’s Federal Commission for the Protection Against Health Risks (Cofepris) issued a health alert on May 27 warning consumers about counterfeit Ozempic circulating across the country. The flagged product is Ozempic 0.25 mg to 0.5 mg semaglutide injectable solution, and the agency says its unknown origins pose serious health risks.

The counterfeit batch carries lot number PP5K617 with an expiration date of August 2026. Its key identifying feature is a pre-filled pen that differs from Novo Nordisk’s genuine FlexTouch device. Cofepris launched its investigation after Novo Nordisk México, the drug’s authorized importer, submitted a technical and documentary analysis flagging the fake product.

Second Counterfeit Ozempic Alert in Two Months

This is the second Cofepris alert about counterfeit Ozempic in under two months. In late March, the regulator warned about falsified Ozempic and another cancer medication, Tagrisso, at the same time. The repeated alerts point to a persistent counterfeiting problem for one of the world’s most sought-after medications.

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Ozempic is an injectable drug approved for type 2 diabetes treatment and, under medical supervision, for weight management. Its popularity has driven global shortages and created a lucrative market for counterfeit versions. In the United States, the FDA seized hundreds of fake Ozempic units in April 2025.

What to Do if You Bought This Lot

Cofepris warned that the counterfeit product’s raw materials, manufacturing conditions, storage, and transport are all unknown, meaning it could contain contaminants or incorrect dosages. Anyone who purchased lot PP5K617 should stop using it immediately and see a doctor.

Patients who experience adverse reactions after using a suspect product can report them through Cofepris’s electronic platform, VigiRam, or by emailing farmacovigilancia@cofepris.gob.mx. The agency has ordered pharmacies to pull the flagged lot from shelves.

Cofepris also reminded the public that Ozempic requires a prescription under Article 226 of Mexico’s General Health Law. Using it without medical supervision carries its own set of risks. Before administering any injectable medication, consumers should inspect the packaging to verify lot numbers and expiration dates, and confirm the pen shows no signs of tampering.

For residents in Baja California who regularly purchase prescription medications at local pharmacies, the lot number PP5K617 and the non-FlexTouch pen design are the two red flags to check. Anyone with information about where the counterfeit product is being sold can file a complaint directly with Cofepris.

This story was first reported by Mexico News Daily and El Financiero.