Regulatory Safety Updates
Daily changes from official regulators: safety signals, DHPCs, restrictions, recalls, risk-management plans and product-information updates.
Ibuprofen, fampridine and PMDA safety measures
Russian batch-quality actions for ibuprofen and linezolid; a Canadian PMS-FAMPRIDINE recall; and new PMDA risk signals and PRECAUTIONS revisions.
Read the full updateClozapine monitoring; insulin and Sarclisa recalls
Swissmedic revised clozapine ANC monitoring; Health Canada recalled specific Sanofi insulin units and Sarclisa vials after possible freezing.
Read the full updateNew safety measures for Tysabri, macitentan, Remsima and GLP-1 medicines
Roszdravnadzor, Swissmedic and HSA published new risk-minimisation measures, restrictions and warnings.
Read the full updateMeropenem leaflet errors and IMAAVY glass-particle recall
The MHRA corrected sodium and strength information in the leaflet supplied with seven Meropenem 1000 mg lots; Health Canada recalled two IMAAVY lots because they may contain glass particles.
Read the full updateANSM recalls three Flebogamma DIF lots following increased hypersensitivity reports
Precautionary recall of three human normal immunoglobulin lots following an increase in reported serious and non-serious allergic and hypersensitivity reactions.
Read the full updateFive medicine-safety updates — 22 September 2026
Two critical FDA injectable-drug recalls; TGA action on Andrographis; and Ukraine SEC communications on Cabazitaxel Accord and laronidase.
Read the full updateFive medicine-safety updates — 21 September 2026
EMA reviews of ipidacrine and sodium oxybate; FDA’s Kybella warning; HSA data on chlorhexidine-associated anaphylaxis; and a package of 27 safety-information updates from Uzbekistan.
Read the full updateFour medicine-safety updates — 18 September 2026
Yimmugo batch recall after serious hypersensitivity reactions; circulation stopped for Drotaverin-Ellara over visible particles and clarity failures; a Valerian tincture batch recall; and Lareb’s COVID-19 vaccination safety report with no new or unexpected adverse reactions.
Read the full updateSeven medicine safety updates — 17 September 2026
Cabergoline postpartum risks; vitamin B6 deficiency and seizures with levodopa combinations; Evrysdi particles; levamisole-associated leukoencephalopathy; a rifampicin batch withdrawal; persistent RSV-prevention medication errors; and a vitamin B6 labelling recall.
Read the full updateTZIELD: serious viral reactivation risk and new safety measures
Serious and life-threatening EBV and CMV reactivation prompted new contraindications, viral-load screening, monitoring and permanent-discontinuation criteria for teplizumab.
Read the full updateTwo high-priority medicine safety alerts — 14 September 2026
A nationwide recall of six compounded injectable lots for elevated bacterial endotoxins and a counterfeit “retatrutide” product containing undeclared high-concentration semaglutide after a serious injury.
Read the full updateSeven 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.
Read the full updateFour 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.
Read the full update15 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.
Read the full updateFour 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.
Read the full updateThree 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.
Read the full updateCorrective 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.
Read the full updateFour 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.
Read the full updateFive 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.
Read the full updateTwo 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.
Read the full updateFive 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.
Read the full updateTwo 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.
Read the full updateThree 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.
Read the full updateFive 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.
Read the full updateNine 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.
Read the full updateFour 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.
Read the full updateThree Medicine Safety Updates — 14 August 2026
Tyenne recall for glass particles, a pms-IRBESARTAN tablet mix-up and extended contraception after CellCept.
Read the full updateRoszdravnadzor 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.
Read the full updateTwo Medicine Safety Updates: Meningioma Risk and Falsified DARZALEX
Meningioma risk with desogestrel/etonogestrel and WHO warning on falsified DARZALEX batches.
Read the full updateTen Important Medicine Safety Updates — 11 August 2026
Ten confirmed topics covering new warnings, severe adverse reactions and risk-minimisation measures.
Read moreFive New Medicine Recalls in the United States and Russia — 10 August 2026
Five officially confirmed medicine recalls associated with documented patient-safety risks.
Read the full update3 Important Drug Safety Updates — 3 August 2026
Three newly verified medicine-safety developments from official regulatory sources.
Read the full updateUzbekistan: Additional Monitoring of Medicines
Requirements for black inverted-triangle labelling and prompt adverse-reaction reporting.
Read the full update6 Important Drug Safety Updates — 28 July 2026
Six relevant safety updates selected from official regulator publications.
Read the full updateNo publications match the selected filters.
PharmExpert monitors official regulatory sources daily and distinguishes confirmed facts from items requiring primary-document verification.