Unacceptable risk


alert shortage warning

The TGA has advised a recall of one Hydralyte flavour, which poses an unacceptable risk to pregnant women

Care Pharmaceuticals Pty Ltd, in consultation with the TGA, is recalling 10 batches of Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets due to the presence of Carthamus tinctorius flower (safflower flower) as an inactive ingredient.

The level of exposure of Carthamus tinctorius flower in this product poses an unacceptable risk if used in pregnancy.

The recall affects all batches within the current expiry date (10 batches in total).

The affected batch numbers are:

  • L9136/1
  • L9198/7
  • L9268/5
  • L9309/1
  • L0108/11
  • L0205/4
  • L0031/7
  • L0031/8
  • L0066/4
  • L0311/5

Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets is a listed complementary medicine (AUST L 288102) used to relieve the symptoms of dehydration.

Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets.

The TGA says that it recently became aware that Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets includes Carthamus tinctorius flower as an inactive ingredient.

The level of exposure of Carthamus tinctorius flower in this product poses an unacceptable risk if used in pregnancy.

The TGA investigation concluded that the safety of Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets was unacceptable as it may expose consumers to Carthamus tinctorius flower during pregnancy.

Further, the product does not contain the mandatory label warning “Do not use if pregnant or likely to become pregnant” due to the inclusion of Carthamus tinctorius flower as an inactive ingredient.

This issue does not affect any other Hydralyte flavours or products, the TGA notes.

It advised consumers that if they are pregnant or if becoming pregnant was a possibility, they should stop using this variant.

It said they can return remaining product to the place of purchase for a refund.

The TGA asked health professionals to be aware of the issue and advise patients accordingly.

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