Mexico’s pharmaceutical market is facing renewed scrutiny as regulators continue to issue alerts involving counterfeit, falsified and stolen medicines — including treatments used for cancer, diabetes, fertility, hormone therapy and other medical conditions.
At the center of those warnings is COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), Mexico’s federal health regulator.
Between November 2025 and May 2026, COFEPRIS issued 30 alerts involving counterfeit or unapproved products and another 12 related to pharmaceutical theft, according to a review by the Partnership for Safe Medicines.
Those alerts included cancer treatments such as Keytruda, Kisqali and Tagrisso, as well as medications used for diabetes and weight management, including Ozempic, Victoza and Rybelsus. The irregularities varied considerably, from falsified lot numbers to incorrect packaging.
COFEPRIS received 45 complaints involving suspected counterfeit medicines in 2018, compared with more than 250 annually since 2022, according to industry and regulatory figures cited by El Economista. Nearly 1,500 reports were recorded between 2020 and 2025.
Recent COFEPRIS Alerts for Counterfeit Medications
On September 2, COFEPRIS warned about counterfeit Choragon® 5000 UI, an injectable form of human chorionic gonadotropin, or hCG, a hormone used in fertility treatment to trigger ovulation. HCG can also be used in certain cases of male infertility related to hypogonadism.
Ferring, the pharmaceutical company that distributes and imports Choragon in Mexico, reported suspicious products showing expiration dates in 2027 and 2028, although the original expiration date was November 2022. Another lot had not been commercialized by the company. Ferring also told regulators that it has not marketed this particular Choragon in Mexico since 2023.
That same day, COFEPRIS issued an alert involving counterfeit Zirabev®, a targeted treatment used for several types of cancer.
Pfizer reported a product carrying lot number GH6769 and an expiration date of June 2027; the original product associated with that lot expired in July 2025. COFEPRIS also noted spelling errors on the counterfeit packaging and said the product's safety, quality and effectiveness could not be guaranteed.
A separate August alert involved PRIMOTESTON® Depot, an injectable testosterone medication.
Bayer identified mismatched lot numbers between the product's inner and outer packaging. In one case, the small glass container holding the injectable medicine was labeled as diclofenac — a nonsteroidal anti-inflammatory drug for pain — rather than testosterone.
COFEPRIS said the origin and manufacturing, storage and transportation conditions of the suspect products could not be verified.
Stolen Medications Pose Additional Risks
A September alert identified five medications stolen from the legitimate supply chain:
Alin Depot: Contains dexamethasone and is used to reduce inflammation and allergic reactions.
Synalar-C: A cream used to treat some forms of dermatitis.
Synalar Simple: A topical medication used for acute dermatitis.
Synalar-O: An ear solution used for infections.
Neuralin: An injectable product containing B vitamins, lidocaine and dexamethasone.
The regulator said the stolen products represented the entirety of the affected lots manufactured or commercialized in Mexico. Once stolen, their storage and transportation conditions are unknown, meaning their stability, quality, effectiveness and safety can no longer be guaranteed.
COFEPRIS also maintains a list of irregular health-product distributors and businesses. Its August 2026 update lists 163.
Problems included missing operating notices, suspensions and sanitary conditions that COFEPRIS could not verify. In some cases, the regulator couldn't find the business at its listed address at all.
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