Andrographis recall: Cold and flu medicine recalled after allergic reaction spike

Popular cold-and-flu medicines containing andrographis have been recalled across Australia after the herb was linked to increasing anaphylactic reactions.

The Theraputic Goods Administration says medicines containing Andrographis paniculata, known as Andrographis, will no longer be listed as a low-risk product for consumers.

“Following a large increase in the number of reports of anaphylaxis in 2019, the TGA has continued to receive a sustained high number of reports of anaphylaxis associated with Andrographis‑containing medicines, which is inconsistent with a listed medicine that would be considered a low-risk medicine,” a TGA statement said.

“A fatal case was reported in June 2024.”

Andrographis is commonly found in Chinese and Indian traditional medicine practices to treat influenza and the common cold, and is often available over-the-counter at pharmacies, or on shelves in health food shop sand supermarkets.

It is not known why andrographis can cause such severe allergic reactions, but factors which may increase the risk of anaphylaxis include the use of anti-inflammatory medicines such as ibuprofen, viral infections, exercising after ingesting the medicine, and alcohol use.

Products including BioCeuticals Armaforce and Clinical ImmuneForce have been recalled, as well as Faulding Immune Combat, PM Lung Support II, Immune Support Echinacea Plus, Chemists’ Own Provance Immune Defence and 28 PLUS Immune Defence, and Nourex Professional Immune Defence.

The Australian Pharmacist is reporting Bioceuticals has already “ceased releasing stock for supply” in response to the recall.

The TGA announcement was made on September 1, but the TGA has warned it will “start taking” regulatory action against retailers who have not recalled the products from mid-October.

“The TGA considers that delaying implementation of this change would likely pose an imminent or serious risk of injury to consumers,” the statement said.