Three medicine safety updates: Aminoselekt, ZOLERIX and Injectafer

2 September 2026 — PharmExpert regulatory safety update

Three previously unreported medicine-safety materials were identified during an expanded review of official regulatory sources.

Azerbaijan: Aminoselekt batch 2500231 recalled

Azerbaijan’s Analytical Expertise Center (AEM) reports a Class 1, Level A recall of Aminoselekt 250 ml intravenous infusion solution, batch 2500231 (expiry 30 September 2026). Visible black foreign particles were found in the solution. The action extends to the end user and prohibits import, wholesale and retail sale of the affected batch.

Official AEM notice

Russia: ZOLERIX risk-minimisation materials

Roszdravnadzor information letter No. 01I-1012/26 provides patient risk-minimisation materials for ZOLERIX (zoledronic acid). The guidance focuses on osteonecrosis of the jaw: dental assessment before treatment, careful oral hygiene and regular dental review, disclosure of treatment before dental procedures, and prompt medical and dental advice for loose teeth, pain, swelling, non-healing sores or discharge around the jaw.

Roszdravnadzor notice and attachment

United States: FDA adds Boxed Warning for Injectafer

The US FDA added a Boxed Warning to ferric carboxymaltose injection (Injectafer) labeling because symptomatic hypophosphatemia continues to be reported. Clinical consequences may include weakness, fatigue, confusion, seizures and cardiac arrhythmias; prolonged severe cases may cause osteomalacia and fractures.

FDA recommends correcting pre-existing hypophosphatemia, checking phosphate before repeat treatment in at-risk patients or when another course is given within three months, monitoring patients at risk of chronic low phosphate, treating hypophosphatemia, and considering permanent discontinuation for severe symptomatic or persistent cases.

Official FDA Drug Safety Communication

This article summarises official regulatory communications and does not replace local product information or clinical judgment.