Specific Flebogamma DIF, Yimmugo and Gamunex batches have already been withdrawn in certain EU member states after allergic-reaction clusters. EMA says the new review covers all human normal immunoglobulins to assess whether further safeguards are needed.
EMA says its Pharmacovigilance Risk Assessment Committee, known as PRAC, has started a safety review covering all human normal immunoglobulin medicines after increased reports of allergic reactions associated with specific batches. Its October 30 announcement follows precautionary withdrawals of particular Flebogamma DIF, Yimmugo and Gamunex batches in certain EU member states. Those recalls concern specific batches; the new review examines the whole medicine class.
These medicines help prevent infections in people who lack enough antibodies, including some patients with immune disorders or blood cancers. They also treat certain conditions in which the immune system attacks the body’s own tissues.
Allergic reactions are a known side effect, but EMA says reports suggest they may be occurring more frequently than expected with particular batches. Reported reactions range from rash and itching to potentially life-threatening anaphylaxis, a sudden severe allergic reaction, and angioedema, rapid swelling under the skin that can affect the face and throat.
EMA says investigations have not established the cause of the clusters, and whether other human normal immunoglobulins could be affected remains unclear. The review therefore includes medicines given into a vein, under the skin or into a muscle.
An HPRA notice refers to a Flebogamma DIF recall letter dated 11 September 2026. It says no manufacturing issues or quality defects had been identified at that point. Separately, an AMK notice says Biotest Pharma GmbH recalled Yimmugo batches after increased reports of severe allergic reactions, mostly involving the onset of anaphylaxis.
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| Medicine | Batch identifiers |
|---|---|
| Flebogamma DIF | G04K139941 (10 g/100 ml vial); G04K192351 (20 g/200 ml vial) |
| Yimmugo | C795945P03; C795945P04 |
The HPRA notice instructs pharmacies and facilities to identify and quarantine affected stock, including units on wards and in clinics. Pharmacies should telephone patients or carers to request the return of unused units and arrange collection through wholesalers. Biotest told AMK that all pharmacies supplied with the affected Yimmugo batches had already been informed of the recall.
EMA reminds healthcare professionals to follow existing product warnings and precautions, including monitoring patients during treatment. Patients should seek medical attention without delay for rash, dizziness, palpitations, wheezing or difficulty breathing, even if they previously tolerated treatment without such reactions.
PRAC will request relevant data from companies marketing these medicines and assess them alongside the available evidence to investigate possible causes and decide whether further measures are needed to reduce risk. EMA will communicate the review’s outcome.
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