Regulatory Safety Updates
Daily changes from official regulators: safety signals, DHPCs, restrictions, recalls, risk-management plans and product-information updates.
Medicine and device safety updates: 20 October 2026
Official safety updates on medicines, devices and pharmacovigilance.
Medicine and device safety updates: 19 October 2026
Official communications on medicine and device safety and risk minimisation.
Medicine and device safety: review as of 16 October 2026
Official MHRA, EMA, Ukraine SEC, Health Canada, ANSM, ANVISA and TGA communications on medicine and device safety, risk minimisation and pharmacovigilance procedures.
Argatroban and PEDMARQSI recalls, EMA updates and device safety — 15 October 2026
FDA and TGA recalls, EMA product-information and risk-management changes, Health Canada device notices, HPRA field-safety notices and an ANVISA device correction.
Pharmacovigilance and regulatory safety updates — 14 October 2026
Official updates from Roszdravnadzor, TGA, Lareb, Swissmedic, ANVISA and EMA, including a batch recall, safety warnings and product-information changes.
IBUPROFEN VELFARM, Pedmarqsi and AYUNA AMA CARE Recalls
Twenty topic groups covering recalls, safety-information changes, risk minimisation and corrective actions.
Regulatory Safety Updates: Eliquis, Capoten, Brevital and New Recalls
Fourteen official materials in 13 topic groups covering risk minimisation, recalls, corrective actions and safety-information updates.
Regulatory Safety Updates: Ocrevus, SFDA Signals and Regulator Actions
New official materials on Ocrevus, SFDA potential signals, recalls and product-information updates.
Eight new medicine-safety updates
Risk-minimisation materials, three batch actions, an anamorelin/posaconazole contraindication, ANSM’s GLP-1 report and withdrawal of El Toro containing undeclared sildenafil.
ANSM recalls Ganirelix Theramex batch over an impurity
Batch 250208 (EXP 04/2029) is recalled from pharmacies and distribution after stability studies found an impurity above the acceptable limit.
Health Canada nitrosamine recalls and MHRA MOVICOL recall
Type II recalls covering 43 carvedilol lots and six diphenhydramine lots over nitrosamine impurities, plus an MHRA Class 3 recall of two MOVICOL Plain batches.
Four medicine safety updates: ciprofloxacin, noradrenaline, thiocolchicoside and undeclared PDE-5 inhibitors
Possible ciprofloxacin–SIADH association, NORADRENALIN AGETAN labelling non-compliance, KONTROLFLEX genotoxicity risk minimisation, and withdrawal of four products containing undeclared active substances.
TGA Andrographis recall and MHRA levetiracetam safety update
Class I recall of seven Andrographis batches over anaphylaxis risk, plus missing safety information for 13 Levetiracetam Neuraxpharm batch entries.
Four medicine safety updates from Roszdravnadzor and Swissmedic
Epkinly and Topalepsin risk-minimisation materials, a Losartan-Xantis lot recall, and 22 Swissmedic product-information changes.
Four medicine safety updates from MHRA, Ukraine, Medsafe and NMPA
Parenteral-nutrition and other MHRA safety measures; increased mortality with dexmedetomidine in ICU patients aged ≤65; GLP-1 receptor agonists and persistent visual loss; and warnings on ADHD stimulants and ferric carboxymaltose.
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.
Clozapine monitoring; insulin and Sarclisa recalls
Swissmedic revised clozapine ANC monitoring; Health Canada recalled specific Sanofi insulin units and Sarclisa vials after possible freezing.
New safety measures for Tysabri, macitentan, Remsima and GLP-1 medicines
Roszdravnadzor, Swissmedic and HSA published new risk-minimisation measures, restrictions and warnings.
Meropenem 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.
ANSM 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.
Five 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.
Five 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.
Four 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.
Seven 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.
TZIELD: 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.
Two 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Three Medicine Safety Updates — 14 August 2026
Tyenne recall for glass particles, a pms-IRBESARTAN tablet mix-up and extended contraception after CellCept.
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.
Two Medicine Safety Updates: Meningioma Risk and Falsified DARZALEX
Meningioma risk with desogestrel/etonogestrel and WHO warning on falsified DARZALEX batches.
Ten Important Medicine Safety Updates — 11 August 2026
Ten confirmed topics covering new warnings, severe adverse reactions and risk-minimisation measures.
Five New Medicine Recalls in the United States and Russia — 10 August 2026
Five officially confirmed medicine recalls associated with documented patient-safety risks.
3 Important Drug Safety Updates — 3 August 2026
Three newly verified medicine-safety developments from official regulatory sources.
Uzbekistan: Additional Monitoring of Medicines
Requirements for black inverted-triangle labelling and prompt adverse-reaction reporting.
6 Important Drug Safety Updates — 28 July 2026
Six relevant safety updates selected from official regulator publications.
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