A new Product recall was launched on June 4, 2025 for bottles of physiological serum brand Happylabsold in 500 ml and 1 liter formats in pharmacies and drugstores. These products are likely to contain Cleaning alcohol traceswhich can lead to side effects. The recall is extended to all the lots made on the site of the Portuguese producer GSLincluding mediphysio, Stentil or Ainsifont brands.
Details of the products recalled
At the end of April, two prizes of physiological serum of the Happylab brand were removed from the market due to the presence of alcohol traces in bottles. Following this problem, the Portuguese organization responsible for drug safety, Infarmed, led an inspection of the production facilities of the manufacturer GSL. On May 12, the national drug safety agency and health products (ANSM) reveals That this inspection has revealed a lack of control over good manufacturing practices, in particular with regard to the cleaning of tanks with 96 %ethanol, which was neither sufficiently controlled nor documented. Mediphysio (20 lots) and Stentil (11 lots) were recalled.
ANSM announced the addition of new lots to the list of products concerned on Wednesday. The references are as follows:
- Brand :: Happylab
- Models / references :: Physiological serum 500 ml and 1 liter
- Lot numbers :: 25034 (1L) And 25045 (500 ml) + Other lots according to the full list in PDF
- Packaging :: 500 ml and 1 liter bottles
- Manufacturers mentioned :: GSL Or Hidrodipro
- Sales area :: Whole France
- Distributors :: Pharmacies and parapharmacies
- Recall nature :: Volunteer, without prefectural decree
- Date of publication of the recall :: June 4, 2025
- Attachment : List of prizes concerned
What are the dangers for health?
The products concerned should be sterile and safe. However, the presence of alcohol, even in small quantities, can cause undesirable effects if applied in the eyes, nose or ears, especially in infants or young children.
According to the ANSM, the ethanol residues detected can cause local irritation or burning sensations. The risks increase in the event of prolonged or repeated use, especially on the mucous membranes or in people with sensitive skin. In case of doubt or symptoms such as redness, tingling or drought, it is recommended to consult a health professional.
To date, no serious incident has been reported. However, the agency advises people who bought these products to throw them or bring them to their pharmacy or parapharmacy.
What if you have these products at home?
The ANSM recommends checking the batches indicated on the packaging. If you have these products:
- Do not use them;
- Bring them to your pharmacy to be eliminated;
- Consult a doctor if you have seen unusual effects.
New lots could be added to the list in the coming days, as quality surveys continue.
How to be reimbursed?
Consumers must Check the lot number Registered on the bottle. If it appears in the PDF list of prizes recalledthe bottle must not not be used. It is recommended to Report in pharmacies or drugstoreswhere he can be Refunded or exchangedeven without a receipt.