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ANSM recalls three Flebogamma DIF lots following increased hypersensitivity reports

  • 23-09-2026
  • Posted by: Eldaniz Hasanov
  • Category: Regulatory Updates
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On 22 September 2026, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced a precautionary recall, agreed with Grifols France, of three lots of the human normal immunoglobulin Flebogamma DIF.

Affected lots

  • Flebogamma DIF 50 mg/ml, 400 ml — lot G04L043941, expiry 02/2028;
  • Flebogamma DIF 100 mg/ml, 100 ml — lot G04K139941, expiry 08/2027;
  • Flebogamma DIF 100 mg/ml, 200 ml — lot G04K169391, expiry 10/2027.

Reason for the regulatory action

The action follows an increase in reported serious and non-serious allergic and hypersensitivity reactions associated with these lots. ANSM notes that hypersensitivity is an identified risk of immunoglobulin medicines and is described in the approved product information.

At the time of publication, no anomaly had been identified in the manufacturing process or in the required quality controls. The recall is being conducted directly with affected healthcare institutions and patients who received the lots through hospital outpatient dispensing; no general alert number was assigned.

Practical implications

Healthcare organisations and professionals should check available stock and products supplied to patients against the listed lot numbers and follow the instructions issued by ANSM and the manufacturer. Clinical decisions should be based on the official communication and approved product information.

Official source: ANSM communication dated 22 September 2026.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on the official communication issued by ANSM and current as of 22 September 2026. It is not medical or legal advice, does not replace the official source, and does not imply wrongdoing by the manufacturer/marketing authorisation holder or a quality concern affecting the company’s entire product portfolio. Company and product names are used only to identify the official material accurately. Decisions should be based on the primary source, the regulator’s instructions and the approved product information.