Unborn babies could be at risk from potassium chloride supplements found to contain unacceptably high levels of lead which could be dangerous when taken by pregnant women.
The popular potassium chloride supplement Slow-K/Duro-K, manufactured by Novartis, contains lead levels above what's acceptable for human consumption under Australian guidelines.
Doctors have been told to consider alternative supplements for pregnant women or anyone taking more than two 600mg pills a day for an extended period.
Australia's Therapeutic Goods Administration (TGA) on Friday said the company was withdrawing the product.
But Novartis said it had informed the TGA of the issue but the TGA had not recommended the pills be recalled "at this stage".
The company said because it had "significant market share" of the supplement in Australia a recall could adversely impact some patients.
Novartis said the supplement still had a favourable "benefit/risk profile" and patients should consult their doctor before making any decision.
A company note sent to doctors, seen by AAP, informs them of "an emerging safety issue" with the pills and explains Novartis is exploring options for sourcing alternative product from around the world.
"It is important for patients to continue to take their medicine as instructed by their healthcare professional," a company spokesman said in a statement.
The TGA said it had been dealing with the sponsor to get results for batches supplied to Australia and will also carry out its own testing.
"The company is withdrawing their product but there are alternatives for patients," a spokeswoman said in a statement.
"Our initial analysis of the data is that there are no concerns for Australian patients as a result of using this product."