In May 2025, the French National Agency for the Safety of Medicines (ANSM) published a major alert: several batches of physiological serums sold in pharmacies were withdrawn from the market for non-compliance. The cause: the presence of traces of cleaning alcohol in the bottles, linked to a failure in the manufacturing process.
This recall, which affects brands such as Happylab, Mediphysio, Stentil, and Ainsifont, raises a key question for pharmacists, laboratories, and distributors: What guarantees should you demand from your physiological serum manufacturer?
A health alert revealing a lack of quality control
The case began with an inspection by the Portuguese health authority at the production site of GSL Produtos Químicos e Farmacêuticos, the manufacturer of the recalled batches. The inspectors identified a insufficient mastery of good manufacturing practices (GMP), in particular a lack of rigor in the cleaning of ethanol tanks 96 %.
Result: alcohol residues were found in 500 ml and 1 liter bottles, which were supposed to contain only a sterile 0.9 % sodium chloride solution. This contamination, even at low doses, is unacceptable for a product for ocular, nasal or cutaneous use, particularly among sensitive populations (infants, elderly people, hospital care).
Brands affected by the recall of physiological serums
The alert mainly affects the following brands:
- Happylab
- Mediphysio
- Stentil
- GSL
- Thusfont
The bottles concerned are generally 500 ml or 1 L, sold in pharmacies, drugstores and sometimes used in medical and social establishments. Consumers are invited to do not use products from the affected batches and return them for reimbursement.
This situation has a direct impact on the confidence of pharmacies and groups, who turn to their suppliers for explanations… and solid guarantees.
What should you expect from a saline solution manufacturer?
This article highlights the importance of choose a manufacturer who controls its entire production chain, and complies with strict European regulations. Here are the essential points to validate:
1. Controlled, validated, documented sterility
Physiological serum is a sterile class I medical deviceIts production must comply with the standards:
- EN ISO 13485: Quality systems for medical devices
- ISO 14971: Risk management
- ISO 10993: Biocompatibility
- ISO 15223-1: Labelling and product information
The manufacturer must be able to provide the certificates of conformity, THE validation reports processes, and the traceable batch records.
2. Validated cleaning processes
In the current recall, it is the cleaning of the ethanol tanks that has been singled out. It is imperative that any cleaning process be documented, validated and reproducible.
A good manufacturer uses clear procedures, with verification tests (rinsing, residual dosage, microbiological validation) after each cycle.
3. Transparent quality monitoring
A reliable actor must be able to provide on request:
- THE lot numbers associated with orders
- THE sterilization protocols used
- There traceability of raw materials
- External audits and inspections carried out
The Smart Agents Healthcare Response
At the house of Smart Agents Healthcare, we have been supporting laboratories, pharmaceutical groups and distributors for over 15 years in the manufacture of physiological serums white label.
Our physiological serum is:
- 100 % sterile, manufactured according to CE standards (Class I Medical Device)
- Complies with all traceability requirements and quality documentation
- Manufactured in ISO 13485 certified factories with strict protocols
- Packaged in a recyclable, BPA-free bottle
- Available with your own brand, for complete control of your image
👉 This reminder shows that it is not enough to choose a price: you must choose a partner committed to quality and product safety.
How can pharmacies and groups react?
This episode can be an opportunity to:
- Check certificates and supplier files
- Review the white label manufacturing contracts
- Request a traceability guarantee by batch
- Evaluate the possibility of creating a private label with a controlled partner
Groups and brands that offer basic products such as physiological serum under their own brand must be able to guarantee their customers full compliance.
Conclusion: vigilance, transparency and trusting partnership
The massive recall of saline solutions in May 2025 is not just a one-off incident. It reminds all players in the sector that the manufacture of medical devices, even simple ones, requires constant rigor and one total transparency.
For healthcare professionals, laboratories or groups, it is essential to rely on a reliable, certified, and committed manufacturer alongside you to build a solid, reassuring range of basic products that meet field expectations.
