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PharmExpert · Regulatory Intelligence

Regulatory Safety Updates

Daily changes from official regulators: safety signals, DHPCs, restrictions, recalls, risk-management plans and product-information updates.

High importance

Russia, Singapore, Australia and European Union · 8 September 2026

Seven medicine safety updates — 8 September 2026

Four Russian batch withdrawals; a Singapore alert on a weight-loss product containing sibutramine and five undeclared medicines; an Australian Deep Heat recall for bacterial contamination; and an EMA methotrexate label update for epidermal necrosis.

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High importance

European Union, Russia and United States · 7 September 2026

Four medicine safety updates — 7 September 2026

Parenteral-iron safety review; Decaris withdrawal over leukoencephalopathy; a linezolid batch recall for bacterial endotoxins; and a three-lot epinephrine recall for particles and sterility concerns.

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High importance

Multiple regulators · 4 September 2026

15 medicine safety updates — 4 September 2026

Carbidopa/levodopa vitamin B6 monitoring; a temozolomide recall; CADD, Aisys and Carestation device risks; EMA risk-management changes; new PRAC signals; and WHO, CDE and KIDS updates.

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High importance

United Kingdom, New Zealand, China and Spain · 3 September 2026

Four medicine safety updates — 3 September 2026

Parenteral-nutrition filtration; Medsafe prescribing and labelling updates; prescription-only control of dextromethorphan–guaifenesin; and withdrawal of 22 slimming products with undeclared sibutramine.

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High importance

Azerbaijan, Russia and United States · 2 September 2026

Three medicine safety updates: Aminoselekt, ZOLERIX and Injectafer

Class 1 recall of an Aminoselekt batch for visible particles; ZOLERIX materials on osteonecrosis of the jaw; and an FDA Boxed Warning for symptomatic hypophosphatemia with Injectafer.

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High importance

United States, Canada and European Union · 1 September 2026

Corrective medicine safety update: B. Braun, Baxter and Tecfidera

Particulate-related recalls of sodium chloride injections; serious gastrointestinal reactions with dimethyl fumarate; and an administrative EMA PRAC note.

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High importance

United States, Russia, Japan and European Union · 1 September 2026

Four medicine safety updates — 1 September 2026

Lipofit recall for undeclared fluoxetine and DNP; withdrawal of an Indapamide batch; contraindication of tucatinib with palovarotene; and strengthened lithium and avacopan precautions.

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High importance

Russia, Canada, Brazil and Singapore · 28 August 2026

Five medicine safety updates — 28 August 2026

Withdrawal of a substandard Vaseline oil batch; two semaglutide recalls involving dose delivery and an impurity; seizure of falsified Dysport; and a Class 2 Carbimazole recall.

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High importance

Russia and United States · 27 August 2026

Two medicine safety updates — 27 August 2026

QTc prolongation and torsade de pointes warning for donepezil, plus Baxter’s recall of one anticoagulant sodium citrate solution lot for possible fibreglass particles.

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High importance

United Kingdom, Canada, Switzerland, France and United States · 26 August 2026

Five medicine safety updates — 26 August 2026

New warnings for finasteride, dutasteride, sotorasib and elranatamab; a recall of products containing undeclared sildenafil; severe hypertriglyceridaemia with alectinib; Siklos dispensing-error risk; and a recall of 70% Dextrose Injection.

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High importance

Australia and Japan · 25 August 2026

Two medicine safety updates — 25 August 2026

Undeclared prescription-strength hydroquinone in counterfeit CAROTONE products and new PMDA/MHLW evaluations of multiple serious drug-safety signals.

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High importance

Russia, United States and France · 21 August 2026

Three medicine safety updates — 21 August 2026

New Russian GVP/GCP inspection requirements, a Glutathione Injection recall for elevated endotoxins and a Tavneos recall following an unfavourable benefit-risk conclusion.

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High importance

Russia · 19 August 2026

Five medicine quality recalls and restrictions — 19 August 2026

Quality defects affecting specific batches of ketorolac, rifampicin, linezolid, troxerutin and calcium gluconate, including abnormal toxicity, mechanical inclusions and bacterial endotoxins.

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High importance

Multiple regulators · 18 August 2026

Nine medicine safety updates — 18 August 2026

Ipidacrine liver-injury review; recalls involving contamination, particulates and a strength mix-up; ARIA precautions and three apixaban bleeding-risk minimisation packages.

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High importance

Russia and France · 15 August 2026

Four medicine safety updates — 15 August 2026

Three recalls of injectable medicines for impurities or particles and a Temozolomide Accord recall due to a potential double dose.

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High importance

Multiple regulators · 14 August 2026

Three Medicine Safety Updates — 14 August 2026

Tyenne recall for glass particles, a pms-IRBESARTAN tablet mix-up and extended contraception after CellCept.

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High importance

Russia · 13 August 2026

Roszdravnadzor recalls salicylic-zinc paste batch over pH nonconformity

Batch 010326 is being withdrawn after a pH nonconformity; the official notice cites measures to eliminate risks to life and health.

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High importance

Multiple regulators · 12 August 2026

Two Medicine Safety Updates: Meningioma Risk and Falsified DARZALEX

Meningioma risk with desogestrel/etonogestrel and WHO warning on falsified DARZALEX batches.

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High importance

Multiple regulators · 11 August 2026

Ten Important Medicine Safety Updates — 11 August 2026

Ten confirmed topics covering new warnings, severe adverse reactions and risk-minimisation measures.

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High importance

United States and Russia · 10 August 2026

Five New Medicine Recalls in the United States and Russia — 10 August 2026

Five officially confirmed medicine recalls associated with documented patient-safety risks.

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High importance

Multiple regulators · 3 August 2026

3 Important Drug Safety Updates — 3 August 2026

Three newly verified medicine-safety developments from official regulatory sources.

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Medium importance

Uzbekistan · 29 July 2026

Uzbekistan: Additional Monitoring of Medicines

Requirements for black inverted-triangle labelling and prompt adverse-reaction reporting.

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High importance

Multiple regulators · 28 July 2026

6 Important Drug Safety Updates — 28 July 2026

Six relevant safety updates selected from official regulator publications.

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Methodology
PharmExpert monitors official regulatory sources daily and distinguishes confirmed facts from items requiring primary-document verification.