Medicine Recalls
50 recalls from tga.gov.au
Medicines, medical devices, and therapeutic goods recalled by the TGA.
Medicine Recalls results
TGA-508131
activeSpringLeaf Fat Clear
Homart Pharmaceuticals Pty Ltd is recalling specific batches of its product, SpringLeaf Fat Clear, due to two identified compliance problems.
Medicine
22 July 2025
TGA-504747
activeXinyi Biyan Pills
Well Herb is recalling batch numbers: DB0014M & DB0015M with expiry Date 11/12/2027 supplied in Australia of Xinyi Biyan Pills due to the medicine having unacceptable amounts of lead above the permitted daily dose.
Medicine
8 July 2025
TGA-504625
activeUpdate on product correction A40/30 BiPAP Series
Due to ongoing problems with their A30 and A40 series BiPAP devices, Philips is now contacting those affected to organise replacement devices or discuss alternative options.
Medicine
3 July 2025
TGA-503112
activeHeartSine Samaritan Public Access Defibrillators (PAD) 350P, 360P, 500P
Stryker is conducting an Urgent Recall of certain serial numbers of the HeartSine Defibrillators.
Medicine
23 June 2025
TGA-499384
activePentavite Multivitamin + Iron Kids Chewables, pack size 60s
Pentavite Pty Ltd is recalling two batches of Pentavite Multivitamin + Iron Kids Chewables because the product is missing required warning statements on the label.
Medicine
9 June 2025
TGA-499347
activeK Care Seat Walkers
Product Correction: Some K Care Seat Walkers have been supplied without a complete User Manual.
Medicine
3 June 2025
TGA-498161
activeRecall: Weleda Baby Teething Powder, Oral Powder, 60g
Weleda Australia Pty Ltd is recalling one batch of Weleda Baby Teething Powder following a complaint that a fragment of glass was found in one bottle of this product.
Medicine
25 May 2025
TGA-497976
activeEuky Bear Warm Steam Vaporiser
Felton Grimwade & Bosisto’s Pty Ltd is recalling all batches of Euky Bear Warm Steam Vaporiser, Model number EBSV2013 due to a quality problem whereby the enclosed heating element can overheat.
Medicine
20 May 2025
TGA-497383
activeBrauer Baby & Child Teething Gel
Brauer Natural Medicine is recalling several batches of its Baby & Child Teething Gel, 20 g, due to the potential for a small plastic fragment from the tube rim being present in the gel.
Medicine
7 May 2025
TGA-496725
activeRecall: Pad-Pak battery for HeartSine samaritan Public Access Defibrillator (PAD)
Stryker is conducting an urgent recall of certain lots of the HeartSine Samaritan Public Access Defibrillator Pak (PAD-PAK). Stryker is now attempting to reach the small percentage of customers affected.
Medicine
22 Apr 2025
TGA-496726
activeProduct correction: HeartSine samaritan Public Access Defibrillators (PAD) 350P, 360P, 500P
Stryker is conducting an urgent product correction of certain lots of the HeartSine Defibrillator. Stryker is now attempting to reach the small percentage of customers affected.
Medicine
22 Apr 2025
TGA-496774
activeRecall: Blissbaby Flatus tube, single-use Lufti Colic Reliever
Bliss Baby is recalling all batches of ARTG 351147 - Flatus tube, single-use - Lufti Colic Reliever, due to insufficient evidence provided to the TGA to support its safe use.
Medicine
22 Apr 2025
TGA-496188
activeProduct Alert: Vyvanse capsules multiple strength
Takeda Pharmaceuticals Australia has issued a product alert for Vyvanse capsules due to minor packaging errors. The medication is safe to use as prescribed.
Medicine
2 Apr 2025
TGA-496146
activeRecall: Multiple vitamin and perinatal products
Several vitamin and perinatal (including preconception) products are being recalled due to a lack of or excessive levels of potassium iodine.
Medicine
2 Apr 2025
TGA-495496
activeRecall: Reynard Health 0.5% Chlorhexidine swab sticks foam, large foam swab sticks and prep pads 6cm x 6cm
Reynard Health Supplies is conducting a Critical Recall of the above products. A contamination problem has been identified with the products.
Medicine
23 Mar 2025
TGA-486443
activeProduct defect correction / Implant hazard alert: ACCOLADE dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps)
Boston Scientific have advised that subsets of ACCOLADE and VISIONIST pacemakers have an increased risk of permanently entering Safety Mode which has limited functionality.
Medicine
19 Dec 2024
TGA-486081
activeRecall: Caruso’s Natural Health WEE LESS, BLOAT EZE and ASHWAGANDHA 7500
Caruso's Natural Health Pty Ltd is recalling certain batches of WEE LESS, BLOAT EZE and ASHWAGANDHA 7500 due to suspected tampering.
Medicine
9 Dec 2024
TGA-480395
activeProduct defect alert: Omnipod DASH ® PDM U100 (mmol/l)
Insulet is advising they have received complaints of Omnipod DASH PDM/controller battery depletion as a result of the 3G network deactivation in the region.
Medicine
1 Dec 2024
TGA-480394
activeRecall: Accu-Chek Spirit 3.15 ml cartridge system
There is a potential for insulin leakage with the Accu-Chek Spirit 3.15 ml cartridge system due to a manufacturing problem.
Medicine
1 Dec 2024
TGA-441569
activeUpdate on product defect A40/30 BiPAP Series
The affected bi-level positive airway pressure (BiPAP) devices may stop providing therapy on an intermittent or permanent basis and the ‘Ventilator Inoperative’ alarm will sound.
Medicine
3 June 2024
TGA-416957
activePanadol Children 1 Month - 1 Year paracetamol 100mg/mL oral liquid bottle: problem with dosing syringe
If the dosing syringe is stiff and difficult to use, you may not be able to control the delivery of the medicine. This poses a risk of choking, especially for babies.
Medicine
28 Apr 2024
TGA-416419
activeProduct defect alert: A40/30 BiPAP Series
Be alert to the issue of unexpected shut down of the A30 and A40 series bi-level positive airway pressure (BiPAP) devices. This can cause interruptions and loss of therapy for patients.
Medicine
4 Apr 2024
TGA-416284
activeHazard alert: Hintermann Series H3 Total Ankle Replacement System
Be alert about a higher risk of device failure with the Hintermann Series H3 Total Ankle Replacement (TAR) system. Read this if you're a patient, carer or health care provider.
Medicine
3 Apr 2024
TGA-416184
activeProduct defect correction: Fanttest COVID-19 / Influenza A&B Antigen Test Kit - potential for control line variability
The companies supplying Fanttest COVID-19 test kits were made aware of the potential for variability in the way the control line appears (ie a weak/faint/pale control line) when strong COVID-19 positive results are obtained.
Medicine
2 Apr 2024