Mexico Counterfeit Medicines Alert: Four Products and the Lots to Avoid
MEXICO · HEALTH
Key Facts
- —The country In Mexico, the United States’ southern neighbour, medicines are sold in pharmacies and online, and illegally at street markets.
- —Why it matters Cofepris, the federal health-safety regulator, has flagged fake Bayer cold and pain remedies and a fake hormone injection since July.
- —How fakes are found Manufacturers and importers check suspect packs against their records and alert Cofepris when lots or dates do not match.
- —What happened On Monday 28 September Cofepris named fake lots of Saizen, Bedoyecta and Buscapina Compositum, plus the Granulox wound spray.
- —What it means for you Check the lot number on the pack against the alert, and do not buy or use a listed lot.
- —Still open Cofepris has not said how many fake packs were sold, where, or whether anyone was harmed.
Mexico’s federal health regulator on Monday 28 September warned patients about three counterfeit medicines and one tampered wound spray. Cofepris named specific lot numbers not to buy or use, and asked anyone who finds them on sale to report it.
The products are Saizen, a growth-hormone injection, Bedoyecta vitamin capsules, Buscapina Compositum tablets for cramping pain, and Granulox. In each case the company behind it told Cofepris the packs were not its own or carried altered dates.
What Cofepris is and how an alert works
Cofepris, the Federal Commission for the Protection against Sanitary Risks, regulates medicines, medical devices and pharmacies in Mexico. Its role is similar to that of the Food and Drug Administration in the United States.
Each alert rests on what Cofepris calls a technical and documentary analysis of information from the company holding the product’s registration. In the Saizen case, the importer judged from photographs that the inner and outer packaging were not original.
Cofepris then publishes the lots and tells pharmacies and distributors to set aside any such stock. It also asks the public to report sales through its online sanitary complaint system.
The three medicines and the lots named
Saizen 20 mg contains somatropin, a growth hormone, in pre-filled injection cartridges. Merck Biopharma Distribution, its importer and distributor, flagged lots Ba054637, BA010812 and KW010374.
Lot Ba054637 is marked October 2028, although its original expiry was November 2020, and it failed sterility tests. Lot KW010374 also failed sterility tests, and neither it nor BA010812 was distributed by the company.
Cofepris added two further Saizen lots, BA088217 and AB003660, flagged in international notifications. Their expiry dates are listed as April 2027 and July 2027.
Bedoyecta capsules combine B vitamins, folic acid, vitamin C and rutin, a plant compound. Laboratorios Grossman, which holds the registration, said lots 230593 and 230589, marked November 2026, have no packaging or distribution records.
Buscapina Compositum tablets combine hyoscine, which relaxes cramping muscles, with the painkiller metamizole. Sanofi’s Mexican unit reported lots CMXA001, CNXA001, CMXA007, MXA007 and C57411 as falsified.
Old lot numbers, new dates
Several fakes carry real lot numbers whose original expiry dates have passed, printed with new ones. Sanofi said Buscapina lots that expired in 2022 and 2024 now carry dates between December 2026 and December 2029.
Some fakes came in boxes of 24 tablets, a size Sanofi says does not exist for this product. The Granulox wound spray, a medical device rather than a medicine, follows the same pattern of rewritten dates.
Medic Manage, which holds its registration, said lot 16115143 was sold in Mexico with a November 2019 expiry. The same lot later turned up marked December 2026, which Aristegui Noticias described as relabelling by unknown persons.
Cofepris warns that the storage, temperature and handling of such products are unknown. It says their safety, quality and effectiveness therefore cannot be guaranteed.
Not the first alert this year
The 28 September notices are at least the third round of Cofepris alerts on counterfeit medicines since July. On Thursday 23 July it flagged five fake Bayer products, including Tabcin, Flanax and Alka-Seltzer, Infobae reported.
Bayer found lot numbers that did not exist, belonged to other medicines or carried altered expiry dates. On 2 September Cofepris warned of fake Choragon fertility-hormone injections sold online, one with a 2022 expiry shown as 2027, Proceso reported.
Saizen itself is a repeat target, as a June 2024 Cofepris alert on falsified Saizen already named lot Ba054637. Proceso stressed, about the Bayer case, that such an alert does not mean a whole brand is fake.
Shortages, prices and a political argument
Industry voices link counterfeit medicines to gaps on pharmacy shelves and to high prices. A La Silla Rota column on 25 September said the industry group UNEFARM sees shortages and high costs as a root cause.
When a medicine is missing or too expensive, the column argued, patients look in other channels where fakes and stolen goods appear. It said the industry, Cofepris and the health ministry are studying a QR code to trace each pack.
The issue also divides Mexico’s parties, as a debate in the Yucatán state congress showed in April. A cancer patient was said to have received a suspected fake medicine at a Mérida hospital for federal employees, MVS Noticias reported.
“It was not medicine, it was a lie,” said Álvaro Cetina of the conservative National Action Party (PAN). Clara Rosales of Morena, President Claudia Sheinbaum’s left-wing party, called that alarmism and said fakes surfaced under the previous PAN state government.
How to check a medicine in Mexico
For foreign residents, the first safeguard is where you buy. Cofepris advises against buying medicines at street markets, known as tianguis, or at any other informal outlet.
Online sellers should have a physical address in Mexico, a health licence and an operating notice issued by Cofepris. The alerts tell buyers to check all three before ordering from websites, apps or online marketplaces.
At home, compare the lot number and expiry date on the box with those printed on the blister or cartridge. Cofepris gave the same advice in July and asked people to look for signs of tampering, Infobae reported.
Then check the lots against the lists above, since the Buscapina and Granulox warnings apply whatever expiry date the pack shows. Vanguardia stressed this point for Granulox, and an unfamiliar pack size is worth raising with your pharmacist.
El Universal highlighted Cofepris’s advice to anyone who has taken a listed Buscapina lot: stop using it and report any symptoms. Side effects go to VigiRam, the regulator’s online reporting form, and suspected sales to its online sanitary complaint system.
What comes next, and what the alert does not mean
Cofepris says it will keep up its controls and report any new evidence. It has not said how many fake packs it found, where they were sold, or whether anyone has been harmed.
The alert does not mean every box of Saizen, Bedoyecta, Buscapina Compositum or Granulox is fake. It covers only the listed lots, which the companies themselves reported to Cofepris.
Cofepris has not said the fakes reached licensed pharmacies, though it told pharmacies to set aside any listed lot they find. The QR tracing idea, if adopted, would start with high-cost specialist medicines, La Silla Rota’s column said.
Frequently Asked Questions
What is Cofepris?
Cofepris is Mexico’s federal regulator for medicines, medical devices and other health products, comparable to the US Food and Drug Administration. It oversees pharmacies and distributors and publishes health alerts about risky products.
Which counterfeit medicines did Mexico flag on 28 September?
Saizen 20 mg growth hormone (lots Ba054637, BA010812, KW010374, BA088217 and AB003660), Bedoyecta capsules (lots 230593 and 230589) and Buscapina Compositum tablets (lots CMXA001, CNXA001, CMXA007, MXA007 and C57411). The Granulox wound spray, lot 16115143, was flagged for an altered expiry date.
What should I do if I have one of these packs?
Do not use it, and report where it was sold through Cofepris’s online sanitary complaint system. Report side effects through VigiRam or [email protected], and Granulox problems through the regulator’s medical-device incident system. See a doctor if you feel unwell.
Is it safe to buy medicine at a Mexican pharmacy?
Cofepris advises buying from formal, licensed pharmacies rather than street markets or unverified websites. The alerts cover specific lots, not whole brands, and Cofepris has not published how many fake packs circulated.
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