What are fake drugs? Substandard, falsified and unregistered medicines explained

"Fake drugs" covers three different problems: medicines made badly, medicines made to deceive you, and medicines the regulator in your country has not approved. Here is what each one means and why each one can hurt you.

What people mean by fake drugs

"Fake drugs" is the everyday name for medicines that are not what they claim to be. News reports and regulators' alerts also use the word "counterfeit". Health agencies use more exact terms. Each one points to a different cause.

In May 2017, the 70th World Health Assembly agreed on the term "substandard and falsified medical products". It replaced an older label that sometimes mixed up medicine safety with the protection of intellectual property. The World Health Organization (WHO) now sorts poor-quality medicines into three groups: substandard, falsified, and unregistered or unlicensed.

Substandard medicines

A substandard medicine is a product the regulator has approved, but the box in your hand fails its quality standards or specifications, or both. WHO also calls these medicines "out of specification".

Substandard medicines often come from poor manufacturing or weak quality control at the factory. Nobody set out to cheat you, but the medicine may hold the wrong amount of its active ingredient, or the wrong medicine altogether.

In April 2025, Kenya's Pharmacy and Poisons Board flagged substandard batches of three paracetamol injections: Lumidol, Blink and Paragen. In the same alert, it reported a box of S-Prazo esomeprazole capsules that held a strip of levofloxacin tablets, a different medicine. The board told anyone holding the listed batches to stop using them and return them to the nearest health facility or the supplier.

Falsified medicines

A falsified medicine deliberately misrepresents its identity, its contents or where it came from. This is what most people picture when they hear "fake drugs". The people who make falsified medicines copy the look of a real product and sell it to deceive you for profit.

In April 2025, WHO warned about falsified HEALMOXY amoxicillin capsules found in Cameroon and the Central African Republic. Laboratory tests found the capsules held no amoxicillin at all. Someone taking them for a bacterial infection would get no treatment.

Falsified medicines turn up across the continent. In the same April 2025 alert, Kenya's Pharmacy and Poisons Board reported falsified Augmentin, an antibiotic. In November 2024, South Africa's regulator, SAHPRA, reported a rise in suspected counterfeit Ozempic sold through websites and social media. In August 2025, NAFDAC confirmed counterfeit Postinor-2 emergency contraceptive pills in Nigeria, printed with the same registration number as the original.

Unregistered or unlicensed medicines

An unregistered or unlicensed medicine has not been assessed or approved by the national or regional regulator for the market where it is sold. It may be well made somewhere else, but no one in your country has reviewed its quality, its safety or where it came from.

A registration number on the box shows the product went through that review. Fake products can copy a real number. Search the number and compare the name, strength and maker with the box in your hand. Each regulator publishes its own list:

Which medicines get faked

Any medicine can be faked. Of the 1,500 or so reports WHO received from 2013 to 2017, antimalarials and antibiotics came up most often, but the reports ranged from cancer treatments to contraceptives. Africa accounted for 42% of the reports.

Fake drugs are not only cheap copies of old medicines. WHO found the reports were split almost evenly between generic medicines and patented, branded ones. In September 2025, SAHPRA named weight-loss medicines, sexual enhancers and skin-bleaching products among the falsified products common in South Africa.

Fake drugs also reach people through the normal supply chain. A 2023 report by the United Nations Office on Drugs and Crime (UNODC) found that trafficked medicines in West Africa usually arrive through ordinary international trade, mainly by sea, and are often diverted from legal supply chains. The people involved included pharmaceutical company staff, public officials and street vendors.

How fake drugs harm people

The WHO fact sheet on substandard and falsified medical products lists these harms:

  • Poisoning from contaminants or toxic ingredients.
  • Treatment failure: the wrong ingredient or the wrong dose leaves the illness untreated.
  • Illness that gets worse instead of better.
  • Drug resistance: infections that could have been treated become harder to cure.

Africa has seen the worst of these harms. In late 2008 and early 2009, My Pikin Baby Teething Mixture, a syrup sold in Nigeria for teething pain, was found to contain diethylene glycol, a chemical used in antifreeze. By February 2009, Nigeria's Ministry of Health said 84 children had died.

In October 2022, WHO warned that four children's medicines found in The Gambia, including cough syrups, held unacceptable amounts of diethylene glycol and ethylene glycol, and that their use in children could cause serious injury or death. In April 2024, Reuters reported that these two chemicals had been linked to the deaths of more than 300 children in The Gambia, Cameroon, Indonesia and Uzbekistan since 2022.

Across low- and middle-income countries, WHO estimated in 2017 that about 1 in 10 medical products is substandard or falsified. Models cited by WHO in the same year suggest 72,000 to 169,000 children may die each year from pneumonia after taking substandard or falsified antibiotics. A second model estimated 116,000 extra malaria deaths a year in sub-Saharan Africa from substandard and falsified antimalarials. You can read more of the evidence in fake medicines in Africa.

What to do if you think a medicine is fake

  1. Keep the medicine, its box and your receipt. Do not throw them away.
  2. Speak to a pharmacist or doctor as soon as you can. Do not stop a prescribed treatment on your own: ask them for a replacement from a reliable supply.
  3. If you or someone else feels unwell after taking it, get medical help straight away.
  4. Report it to the medicines regulator in your country.
  • Nigeria: NAFDAC, on 0800-162-3322, by email to sf.alert@nafdac.gov.ng, or through Med-Safety.
  • Ghana: the Food and Drugs Authority, on 0551112224 or 0244310297, or at the nearest FDA office.
  • Kenya: the Pharmacy and Poisons Board, at pv.pharmacyboardkenya.org.
  • South Africa: SAHPRA, on its 24-hour hotline 0800 204 307. Report side effects at medsafety.sahpra.org.za.
  • Tanzania: TMDA, at sqrt.tmda.go.tz or by dialling *152*00#.
  • Uganda: the National Drug Authority, on the toll-free line 0800 101 999 or on WhatsApp at 0740 002 070.

For the signs to look for on a box, read how to identify fake drugs. In Nigeria, read how to report a fake product for every channel.

A medicine can look right and still be fake. If something about a box or a tablet worries you, speak to a pharmacist before you take it.

Questions

Are fake drugs and counterfeit drugs the same thing?

In everyday speech, yes. WHO uses "falsified" for medicines made to deceive you and "substandard" for approved medicines that fail quality standards.

Can a fake drug look exactly like the real one?

The differences can be very small. In NAFDAC's 2025 Postinor-2 alert, the counterfeit boxes differed from the original by a misspelt word and smaller print, and they carried the same registration number.

How common are fake drugs?

In 2017, WHO estimated that about 1 in 10 medical products in low- and middle-income countries is substandard or falsified. Africa accounted for 42% of the reports WHO received from 2013 to 2017.

What should I do if I think my medicine is fake?

Keep the box and speak to a pharmacist or doctor, and do not stop a prescribed treatment on your own. Report it to the medicines regulator in your country, such as NAFDAC, Ghana's FDA, Kenya's Pharmacy and Poisons Board, SAHPRA, TMDA or Uganda's National Drug Authority.

Sources

  1. Substandard and falsified medical products (fact sheet) (opens in a new tab)World Health Organization
  2. Definitions of substandard and falsified (SF) medical products (opens in a new tab)World Health Organization
  3. 1 in 10 medical products in developing countries is substandard or falsified (opens in a new tab)World Health Organization
  4. Medical Product Alert N°2/2025: Falsified HEALMOXY (Amoxicillin) Capsules 500mg (opens in a new tab)World Health Organization
  5. Medical Product Alert N°6/2022: Substandard (contaminated) paediatric medicines (opens in a new tab)World Health Organization
  6. PPB issues alert after detection of falsified, substandard medicines (opens in a new tab)The Star (Kenya)
  7. Call to avoid buying fake versions of Ozempic and Mounjaro (opens in a new tab)SAnews (South African Government News Agency)
  8. SAHPRA lists common falsified products in SA including sexual enhancers & skin bleaching (opens in a new tab)Eyewitness News
  9. Public Alert No. 027/2025: Confirmed Counterfeit Postinor2 (Levonorgestrel 0.75mg) in Nigeria (opens in a new tab)NAFDAC
  10. NAFDAC launches database for certified drugs amidst aggressive crackdown on counterfeit pharmaceuticals in Nigeria (opens in a new tab)Nairametrics
  11. Lookout for FDA registration numbers on products, verify before purchasing: FDA cautions Ghanaians (opens in a new tab)MyJoyOnline
  12. Public View of Registered Products (opens in a new tab)Pharmacy and Poisons Board, Kenya
  13. Registered Health Products Database (opens in a new tab)SAHPRA
  14. Tanzania Medicines and Medical Devices Authority (opens in a new tab)TMDA
  15. NDA Closes Illegal Drug Outlets in North Eastern Uganda, Impounds Medicines Worth UGX 100M (opens in a new tab)Uganda Broadcasting Corporation
  16. Wrong manufacturer, wrong dates: How to spot the falsified HIV test kits flooding Ghana's market (opens in a new tab)Graphic Online
  17. Pharmacy and Poisons Board (opens in a new tab)Pharmacy and Poisons Board, Kenya
  18. South African Health Products Regulatory Authority (opens in a new tab)SAHPRA
  19. National Drug Authority (opens in a new tab)Wikipedia
  20. 84 Nigerian children dead from tainted formula (opens in a new tab)NBC News (Associated Press)
  21. WHO says wider alert on contaminated J&J cough syrup is likely (opens in a new tab)VOA Africa (Reuters)
  22. Trafficked medical products kill almost half a million sub-Saharan Africans every year (opens in a new tab)UN News

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