Alerts

We are issuing an updated safety advisory regarding imported counterfeit unregistered melatonin products.

Information and approvals to manage Presolol 200 tablet shortage

TGA continues to see imports of counterfeit Botox vials despite a previous warning issued in July 2025.

Serious Scarcity Substitution Instrument extended due to continued shortages of HRT patch products.

Kmart Australia Ltd is recalling their Anko Small Gel Pak and Anko Large Gel Pak because they contain ethylene glycol, a toxic substance.

The initial Serious Scarcity Substitution Instrument (SSSI) has been extended - refer to new medicine shortage alert: "Extension of substitution approval for shortage of Catapres (clonidine) 150 mcg tablets"

Pharmaceutical companies Novo Nordisk and Eli Lilly are discontinuing some of their insulin products.

The company which has supplied the CellAED devices, RRR Manufacturing Pty Ltd, has gone into liquidation. The liquidators for RRR Manufacturing, are conducting a Critical Recall for all lots of the CellAED device.

Supply constraints will apply to Creon 25,000 unit and 35,000 unit capsules until 30 June 2026.

Key Sun Laboratories Pty Ltd is recalling one batch of Key Sun Kids Travel Sickness Homeopathic Product, due to the risk of a small metal wire being present in the lozenge.

Manasamitra Vakakam tablets pose a serious risk to your health and should not be taken.

Kumar Kalyan Rasa tablets pose a serious risk to your health and should not be taken.

Brahmi Vati tablets pose a serious risk to your health and should not be taken.

Vitality Brands Worldwide Pty Ltd is recalling three batches of Cancer Council Sunscreen Clear Zinc Kids SPF50+ 110g due to the potential for the product to become separated.

We have updated the product warnings for GLP-1 and dual GIP/GLP-1 receptor agonists for two separate safety issues. This relatively new and high-profile class of medicines is used to treat type 2 diabetes mellitus and/or obesity.

THE SHORTAGE HAS RESOLVED AND THE SSSI WILL LAPSE ON 31 MARCH 2026.

The safety information for denosumab products used to treat osteoporosis has been updated to strengthen the existing warning for multiple spinal fractures after discontinuation or delay of treatment.

Bondi Sands Pty Ltd is recalling five batches of sunscreen due to the potential for the lotions to become separated.

Product correction: Ypsomed Australia is reminding users to ensure they use a compatible smart device and operating system (OS) when using the Mylife CamAPS FX app.

Phytologic Holdings Pty Ltd is recalling one batch of Henry Blooms Infant Liquid D3 & K2 with Probiotic due to a dosing syringe error.

This page warns of fire risks associated with hyperbaric chamber devices following an overseas death, emphasising use only by trained professionals and strict adherence to safety instructions.

We have investigated 2 serious adverse event cases in young babies who had EMLA (prilocaine/lidocaine cream) applied to their skin for local anaesthesia. Both cases were likely to have involved overdose.

TGA is issuing a safety advisory about the importation of unregistered GLP-1 products that are being promoted online for weight-loss.

Consumers are advised that several sunscreen products are being recalled by sponsors. This follows preliminary testing evidence indicating that the SPF levels of their products may be lower than what is claimed on their labels.

We are issuing a safety advisory regarding imported unregistered melatonin products following testing by TGA Laboratories.