Four medicine safety updates — 1 September 2026

PharmExpert’s review of official pharmacovigilance sources identified one newly published high-priority recall and closed three clinically important regulator updates from the preceding review period.

United States: Lipofit Extreme Fat Burner 2.0 recalled nationwide

The US Food and Drug Administration published a nationwide consumer-level recall of Lipofit Extreme Fat Burner 2.0, lot 25M12F, expiry 09/2027. Laboratory testing found undeclared fluoxetine in the AM tablets and undeclared 2,4-dinitrophenol (DNP) in the PM tablets.

These substances can cause serious and potentially fatal effects, including dangerous arrhythmias, cardiac arrest, seizures, hyperthermia, bleeding, suicidal thoughts and multi-organ toxicity. Consumers were instructed to stop using the product immediately.

Official FDA recall

Russia: Indapamide batch withdrawn for microbiological purity failure

Roszdravnadzor Information Letter No. 01I-1011/26 concerns Indapamide 2.5 mg capsules, batch 301025, manufactured by Promed LLC. The batch failed the microbiological purity specification.

The regulator ordered circulation to cease and required affected stock to be withdrawn and destroyed in order to eliminate a threat to life and health.

Official Roszdravnadzor notice

Japan: Tucatinib and palovarotene made mutually contraindicated

Japan’s Ministry of Health, Labour and Welfare and PMDA revised precautions for tucatinib and palovarotene. Tucatinib is a strong CYP3A inhibitor and may increase exposure to palovarotene, increasing the risk of adverse reactions. Concomitant use is now contraindicated.

Official PMDA precautions update

Japan: lithium pregnancy precautions and avacopan liver monitoring strengthened

PMDA’s Pharmaceuticals and Medical Devices Safety Information No. 430 describes revised precautions for lithium carbonate in pregnancy, including specialist and perinatal monitoring, and strengthened risk minimisation for serious hepatic impairment with avacopan.

For avacopan, liver tests are recommended every two weeks during the first three months and every four weeks during the following three months, with treatment interruption criteria for significant transaminase elevations.

Official PMDA safety bulletin

EMA: PRAC meeting agenda published

The European Medicines Agency published the agenda for the Pharmacovigilance Risk Assessment Committee meeting of 31 August–3 September 2026. This is an administrative pharmacovigilance update rather than a new final safety recommendation.

Official EMA meeting page

Why this matters

The actions cover undeclared pharmacologically active and toxic substances, a medicine-quality defect with a direct health-risk statement, a clinically important drug interaction and strengthened monitoring for serious hepatic injury.

This summary is based on official regulator publications and does not replace approved product information or local clinical guidance.