In its Sept. 18 announcement, the TGA advised companies to cancel Australian Register of Therapeutic Goods (ARTG) listings of their andrographis products, traditionally used to treat colds, flus and sore throat, and recall them from the market. The authority noted that while existing listed medicines can still be sold, delaying implementation of the recalls would likely pose an imminent or serious risk of injury to consumers.
“Sponsors of listed medicines containing andrographis have been strongly encouraged to take voluntary action by mid-October 2026,” a TGA spokesperson for the Department of Health, Disability and Ageing shared. “If sponsors do not take timely voluntary action, the TGA will start taking regulatory action.”
While andrographis can no longer be used in new listed medicines, products containing the herb can still enter the Australian market through the registered medicines pathway, subject to TGA assessment of their quality, safety and efficacy before approval.
Some brands are also exploring product reformulation, with probiotics and other botanicals being considered as potential replacements.
Product recalls to date
According to a notice from the Therapeutic Goods Administration (TGA), nine products had been recalled as of Oct. 12.
The latest recall was issued by BioCeuticals, known for its ArmaForce andrographis tablets, which are marketed for the relief of common cold/flu and mild upper respiratory tract infection (URTI). The company is also recalling BioCeuticals Clinical ImmuneForce, which would be eligible for refunds.
“In agreement with the TGA, BioCeuticals is conducting a consumer-level recall of its products containing andrographis in Australia,” the brand stated.
Arrotex Pharmaceuticals, Australian NaturalCare Products, PBA Wholesale Pty Ltd, Symbion Pty Ltd and Universal Pharmaceuticals have also issued product recalls.
Information on the TGA’s Database of Recalls, Product Alerts and Product Corrections (DRAC) showed the earliest andrographis product recall was on Sept. 28, starting with PBA Wholesale.
All recalled products were categorized as a Class I hazard, meaning they present a reasonable possibility of serious injury or death.
Reformulation opportunities
With andrographis no longer allowed in listed medicines, brands are exploring alternative ingredients to reformulate their immune health products.
Popular alternatives included prebiotics, probiotics and postbiotics, according to Wayne Coote, founder and chairman of New South Wales-based healthcare ingredient distributor Pathway International, which is in reformulation discussions with at least six brands.
He said that echinacea, a herbal ingredient often used in supplements and paired with andrographis for cold, flu and immune support, is also now gaining renewed interest.
“Brands are also looking at the echinacea ingredient category again, and the branded ingredient option that is being evaluated is Indena’s Polinacea,” Coote said.
Echinacea’s used in combination with andrographis came under scrutiny in 2024, when TGA reported that over 80% of the adverse events associated with andrographis involved multi-ingredient medicines containing both herbs. The TGA also noted that echinacea itself has also been linked to allergic reactions, including anaphylaxis.
Coote said some brands are also exploring pelargonium as an alternative, given its traditional to relieve common cold symptoms and uncomplicated respiratory issues. However, he noted it is not currently approved on the TGA’s Australian Register of Therapeutic Goods (ARTG) register for domestic supply and is available only through Export Only Listings.
“Pathway International is looking at revisiting our previous pelargonium application for approval with the TGA; however, that will not happen in the short term and will only be ready to resubmit later in 2027,” he said.
BioCeuticals introduced new formulations without andrographis days after TGA its ban, including ArmaForce Stress & Immune Support listed in the Australian Register of Therapeutic Goods (ARTG) on Sept. 23.
The product, which is permitted to make indications relating to supporting healthy immune system function and healthy emotional/mood balance, contains several fungi, including cordyceps (Ophiocordyceps sinensis), reishi (Ganoderma lucidum), shiitake (Lentinula edodes) and turkey tail (Trametes versicolor), alongside the probiotic Lactobacillus gasseri.
