Alert Summary
This WHO Medical Product Alert refers to nine lots of falsified IBRANCE (palbociclib). These falsified products have been detected in Cote d’Ivoire, Egypt, Lebanon, Libya and Türkiye and were reported to WHO in November 2025. The falsified products have been offered directly to consumers via online platforms and have also been found at pharmacy level.
IBRANCE (palbociclib) is a medicine used to treat certain advanced breast cancers. Genuine IBRANCE is presented as capsules to be taken orally.
How to identify these falsified products
These products are falsified as they deliberately misrepresent their identity, composition, and source. The genuine manufacturer has confirmed that the products listed in this alert are falsified. Samples of the falsified products have been tested by the genuine manufacturer and were found to contain no active pharmaceutical ingredient. The genuine manufacturer also identified several visual discrepancies on the packaging. Some of the falsified products carry genuine lot numbers but display packaging, serialization, and capsule printing anomalies.
Falsified lot numbers: The following lot numbers are NOT valid for genuine IBRANCE and any IBRANCE product with these lot numbers should be treated as falsified: FS5173, GS4328, LV1850, and TS2190.
Suspicious lot numbers: (likely to be falsified if combined with any indicator below): GK2981, GR6491, GT5817, HJ8710, and HJ8715.
Indicators of falsification include:
- Label states: “Manufactured by: Pfizer, PO Box 29387, Mission, KS 66201”.
- Label contains spelling errors or poor-quality printing.
- Security foil on the bottle shows the Pfizer logo in black ink.
- Capsules marked with black ink “PBC 125” or have no markings.
- Capsules are an unusual color (e.g., bright orange).
Risks
These falsified medicines did not contain any active pharmaceutical ingredient and should therefore be considered unsafe. Their use could result in treatment failure, uncontrolled cancer progression, and a higher risk of death due to lack of therapeutic effect.
It is important to detect and remove any falsified IBRANCE (palbociclib) from circulation to prevent harm to patients.
Advice to health-care professionals, regulatory authorities and the public
Health-care professionals should report any unexpected adverse reactions, lack of therapeutic effects or quality defects to their National Regulatory Authorities or National Pharmacovigilance Centre.
WHO advises increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these falsified products. Increased surveillance of the informal/unregulated market, including online platforms, is also advised. National regulatory authorities/health authorities/law enforcement are advised to immediately notify WHO if these falsified products are detected in their country. If you are in possession of these products, WHO recommends that you do not use them. If you, or someone you know, has, or may have used these products, or suffered an adverse event or unexpected side-effect after use, seek immediate medical advice from a health-care professional or contact a poisons control centre.
All medical products must be obtained from authorized/licensed suppliers. If you have any information about the manufacture or supply of these products, please contact WHO via [email protected].
Annex: Products subject to the WHO Medical Product Alert N°7/2025