Four medicine-safety updates — 18 September 2026

Regulators in Germany, Russia and the Netherlands published four pharmacovigilance and medicine-safety materials identified in PharmExpert’s monitoring on 18 September 2026.

Yimmugo: batch recall after serious hypersensitivity reactions

Germany’s Paul-Ehrlich-Institut published a Biotest Pharma recall of Yimmugo 100 mg/ml (human normal immunoglobulin), 100 ml, batch C795316P01, expiry 31 August 2028. The recall follows an increased number of reports of sometimes severe hypersensitivity reactions, including anaphylaxis, dyspnoea and partly generalised urticaria. Some patients required intravenous antihistamines and corticosteroids. Remaining stock of the affected batch should be returned.

Official source

Drotaverin-Ellara: circulation stopped for batch 391124

Roszdravnadzor letter No. 01I-1076/26 stopped circulation of DROTAVERIN-ELLARA 20 mg/ml solution for intravenous and intramuscular administration, batch 391124. Quality testing identified failures in appearance, clarity and visible particulate matter. The batch must be withdrawn and destroyed.

Official document

Valerian tincture: recall of batch 200925

Roszdravnadzor letter No. 01I-1077/26 records the manufacturer’s recall of Valerian tincture 25 ml, batch 200925, produced by Ivanovo Pharmaceutical Factory. The action follows non-compliance with the packaging-description requirements of the quality specification.

Official document

COVID-19 vaccination: no new or unexpected adverse reactions

The Netherlands Pharmacovigilance Centre Lareb published its report on the autumn 2025 COVID-19 vaccination campaign. More than 2.2 million vaccinations were administered. Lareb received 1,141 reports containing 4,140 suspected adverse reactions; 5% of reports involved a suspected serious reaction. The most frequently reported reactions were feeling unwell, headache, fatigue, muscle pain and injection-site reactions. No new or unexpected adverse reactions were identified.

Official source

Healthcare professionals and patients should follow the instructions issued by the relevant national regulator and consult the official notices for market- and batch-specific details.