Infarmed Pulls 53 FBeauty Cosmetic Lines Off the Market After a Complaint-Triggered Inspection Flags Four EU 1223/2009 Breaches — Circular 059/CD/550.20.001 Suspends Sales as Consumers Are Told to Stop Use

The Autoridade Nacional do Medicamento e Produtos de Saúde (Infarmed, National Authority for Medicines and Health Products) ordered on Saturday 13 June 2026 the immediate suspension of commercialisation and the market withdrawal of 53 cosmetic products for which FBeauty, Lda. is registered as the legally responsible person. The decision is contained in Circular Informativa n.º 059/CD/550.20.001 dated 5 June 2026 and published in full on the Infarmed Alertas portal — the formal document the regulator uses to bind distributors, retailers and pharmacies to a market-action order.

The trigger was a citizen complaint that reached Infarmed earlier this spring. The cosmetovigilância (cosmetovigilance) intake led to a targeted inspection of the FBeauty portfolio sold in Portugal, and the inspection report concludes the 53 products failed to meet the requirements set by Regulamento (CE) n.º 1223/2009 (EU Cosmetics Regulation 1223/2009) and by Decreto-Lei n.º 23/2025. Infarmed identifies four discrete compliance breaches.

The first is the absence of documented boas práticas de fabrico (good manufacturing practices, GMP) — the ISO 22716 standard EU Article 8 incorporates by reference. The second is a gap in the avaliação da segurança (safety assessment) file required under Article 10. The third is an incomplete or missing ficha de informações do produto (product information file, PIF) the EU-resident responsible person must maintain. The fourth is a labelling breach under Article 19, which requires precise rotulagem (labelling) on ingredient list, batch number, function, warnings and expiry or period-after-opening.

Infarmed instructed every entity holding stock to immediately cease commercialisation, withdraw units from sales floors and online listings, and route the products back to FBeauty, Lda. The regulator also warned consumers: "os consumidores que detenham estes produtos devem abster-se da sua utilização" (consumers who own these products should refrain from using them). The full list of 53 reference codes is attached to the circular on infarmed.pt; the file covers a mix of skincare, makeup and personal-care lines.

The 53-product withdrawal is the largest single-brand Infarmed cosmetics order this year and the third major cosmetics enforcement of 2026, after a March action against a skin-rejuvenation product and a separate file on "DIVES MED / Glow X9 Biorevitalization Peel 4ml". A separate contra-ordenação (administrative-offence) file is now opened against FBeauty, Lda. — sanctions under Decreto-Lei 23/2025 run from €2,000 fines for single labelling breaches up to €180,000 for repeat or aggravated GMP failures.

What This Means for Expats and Residents

• Check your bathroom shelf: If you bought any FBeauty product in Portugal — at a pharmacy, parafarmácia, beauty retailer or online — stop using it until you can match the reference against the Infarmed list on the Alertas page at infarmed.pt. Portuguese consumer-protection law (Decreto-Lei n.º 84/2021) requires the seller to handle the return of a recalled product.
• What "responsible person" means: Every cosmetic placed on the EU market must have a single legally responsible person resident in the EU. For FBeauty, that role sits with FBeauty, Lda. When a circular names that responsible person, the suspension binds the whole national distribution network automatically.
• The safety-assessment gap is the load-bearing breach: A missing avaliação da segurança is the breach Infarmed treats most seriously, because it means no qualified assessor signed off on the cumulative safety profile of the formulation. Until that file is reconstructed and audited, the products cannot legally return to shelves.
• How to report a suspected reaction: Infarmed runs a dedicated cosmetovigilância channel on infarmed.pt under "Notificar Cosmetovigilância". Reports are accepted from consumers, pharmacies and healthcare professionals — even after withdrawal.

The full Circular Informativa n.º 059/CD/550.20.001 and the 53-product list are on the Infarmed Alertas portal at infarmed.pt. Consumers can also write to [email protected] for case-by-case guidance.