Four Medicine Safety Updates — 7 September 2026

Regulators published four important medicine-safety actions concerning parenteral iron, levamisole, linezolid and epinephrine. The updates include a class-wide European safety review, a market withdrawal, and two quality-related recalls.

Parenteral iron: European class-wide safety review

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of all parenteral iron-containing medicines following reports of serious hypophosphataemia, hypophosphataemic osteomalacia and fractures.

The review covers ferric carboxymaltose, ferric derisomaltose, ferric gluconate, ferric hydroxide polymaltose complex, iron dextran and iron sucrose. Oral iron products are not included.

Serious cases have been reported after only one or two doses and in patients without recognised risk factors. Diagnosis may be delayed because symptoms can be non-specific. The review will assess the available evidence and determine whether regulatory action is needed.

Levamisole: circulation of Decaris discontinued in Russia

Roszdravnadzor announced the cessation of circulation and suspension of the marketing authorisations for Decaris (levamisole) 50 mg and 150 mg tablets because of the risk of leukoencephalopathy.

The supporting review identified cases after a single dose, with onset ranging from one day to several months. Clear risk factors and effective risk-minimisation measures could not be established. With alternative anthelmintic treatments available, the benefit–risk balance was considered unfavourable.

Linezolid: batch recalled over bacterial endotoxins

Roszdravnadzor announced the recall of Linezolid 2 mg/mL solution for infusion, 300 mL, batch 0150526, manufactured by MOSPHARM. The batch failed the bacterial-endotoxins specification.

The action follows the earlier identification of the non-compliant batch and is intended to eliminate a potential threat to life and health. Healthcare and supply-chain organisations should verify whether the affected batch remains in stock and follow the regulator’s recall instructions.

Epinephrine injection: three US batches recalled

American Regent recalled three batches of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL), NDC 0517-3030-01: 25128L1C0, 25280L1C0 and 26108L1C0. FDA published the nationwide consumer-level recall.

Complaints involved leaking and cracked vials, creating a lack of sterility assurance. The investigation also identified nylon, cellulosic, acrylic, polyethylene and glass particles. Intravenous administration of particulate-contaminated product may cause vascular blockage, pulmonary embolism, permanent organ damage or death. Loss of sterility may also expose patients to contamination. No related adverse events had been reported at the time of the announcement.

Practical priorities

• Review exposure to parenteral iron and remain alert to persistent fatigue, muscle weakness, bone pain and fractures that may indicate clinically important hypophosphataemia.
• Stop supply and use of the affected Decaris products and linezolid batch in accordance with national instructions.
• Identify and quarantine the recalled epinephrine batches and arrange return, replacement or disposal through the supplier.
• Report suspected adverse reactions and product-quality complaints through the applicable national pharmacovigilance channels.

Sources: EMA PRAC meeting highlights, EMA referral, Roszdravnadzor safety monitoring, Roszdravnadzor linezolid recall, and FDA epinephrine recall.

Prepared by PharmExpert from daily monitoring of official regulatory sources.