Quality & complianceOfficial

Grifols recalls one batch of Gamunex 10% immunoglobulin in Germany

🇩🇪 Paul-Ehrlich-Institut · Thu 29 Oct 2026

Grifols Deutschland has voluntarily recalled batch G04L046403 of Gamunex 10% infusion solution, according to an information letter published by the Paul-Ehrlich-Institut.

Grifols Deutschland GmbH has launched a voluntary recall of a single batch of Gamunex 10%, a human normal immunoglobulin solution for infusion. The Paul-Ehrlich-Institut (PEI) published the company's information letter on its website, listing it under immunoglobulin products and safety information.

The affected product is the 400 ml presentation, batch G04L046403, with an expiry date of 31 March 2029 and the German pharmaceutical central number (PZN) 10920606. The letter is dated 28 October 2026, and the PEI page was updated on 29 October 2026.

The text available to VigiEye does not give the reason for the recall. It also does not say how far the recall extends down the supply chain, or what instructions apply to affected stock. Those details are in the full Grifols letter linked from the PEI notice.

As a general point, a voluntary recall is one initiated by the marketing authorisation holder or distributor, rather than ordered by an authority. It is still normally coordinated with the competent authority.

What it means for your team

  • Check stock and distribution records for batch G04L046403 (PZN 10920606, 400 ml, expiry 31 March 2029).
  • Read the full Grifols letter on the PEI website for the recall reason, the scope and the required actions before quarantining or returning stock.
  • Pharmacovigilance and quality teams should confirm whether the batch has been used and follow the instructions in the letter for any related reporting or queries.

Official source: Paul-Ehrlich-Institut ↗

Article written by VigiEye from the official source (Paul-Ehrlich-Institut). AI-assisted; check the source before acting.

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