About pholcodine cough medicines cancelled by the TGA and recalled from pharmacies for safety reasons

Following an investigation into the safety of pholcodine-containing medicines, the TGA has decided to cancel the registration of these medicines in Australia and is recalling them from pharmacies.

The cancellation and recall actions are being taken because of a link between pholcodine-containing medicines and an increased risk of anaphylactic reactions (a sudden, severe and life-threatening allergic reaction) to certain medicines used as muscle relaxants during general anaesthesia (called neuromuscular blocking agents).

Of the 55 pholcodine-containing products in Australia, 44 products currently have stock on shelves in Australian pharmacies and are therefore subject to the TGA's recall. The sponsors (suppliers) of these medicines are each required to initiate a recall as soon as possible, but no later than 8 March 2023. Pharmacies with affected stock will receive a ‘customer letter’ from the sponsor (directly or via their wholesaler) in the coming days. This letter will include specific details regarding quarantining, returning inventory to the wholesaler, credit arrangements, etc.

While the cancellation of these medicines’ registrations take effect on 29 March, pharmacies should act upon the recall instructions as soon as the customer letters are received. Until then, pharmacies may wish to start taking pholcodine products off the shelves. Requests for product images should be directed to the companies that supply these products.

The list of products being recalled is as follows:

1. APOHEALTH DRY TICKLY COUGH RELIEF pholcodine 1mg/mL oral liquid bottle (new formulation)
2. APOHEALTH DRY TICKLY COUGH RELIEF FORTE pholcodine 4 mg/mL oral liquid bottle
3. APOHEALTH DRY TICKLY COUGH RELIEF pholcodine 1mg/mL oral liquid bottle
4. CHEMISTS' OWN DRY TICKLY COUGH FORTE pholcodine 4 mg/mL oral liquid bottle (new formulation)
5. CHEMISTS' OWN DRY COUGH FORTE pholcodine 3mg/mL oral liquid bottle
6. CHEMISTS' OWN DRY COUGH REGULAR pholcodine 1 mg/mL oral liquid bottle
7. CHEMISTS' OWN DRY COUGH pholcodine 1mg/mL oral liquid bottle
8. APOHEALTH DRY COUGH RELIEF PE & NASAL DECONGESTANT oral liquid bottle
9. BLOOMS THE CHEMIST DRY COUGH RELIEF & NASAL DECONGESTANT PE oral liquid bottle
10. CHEMISTS’ OWN KIDDICOL FOR CHILDREN COUGH & COLD oral liquid bottle
11. CHEMISTS’ OWN DRY COUGH PLUS NASAL DECONGESTANT PE oral liquid bottle
12. CHEMISTS OWN KIDDICOL CHILDREN'S COUGH MIXTURE oral liquid bottle
13. LOGICIN DRY COUGH Pholcodine 1mg/mL oral liquid bottle
14. DURO-TUSS DRY COUGH LIQUID FORTE pholcodine 3 mg/mL oral liquid bottle (new formulation)
15. DURO-TUSS DRY COUGH LIQUID 6 YEARS + pholcodine 1mg/mL oral liquid bottle (New Formula)
16. DURO-TUSS DRY COUGH LOZENGES lemon flavour blister pack
17. DIFFLAM PLUS DRY COUGH + ANTIBACTERIAL + ANTI-INFLAMMATORY pineapple lime flavour lozenge blister pack
18. DIFFLAM PLUS DRY COUGH + ANTIBACTERIAL + ANTI-INFLAMMATORY honey lemon ginger flavour lozenge blister pack
19. DURO-TUSS DRY COUGH LIQUID PLUS NASAL DECONGESTANT oral liquid bottle
20. DURO-TUSS DRY COUGH LOZENGES orange flavour blister pack
21. DURO-TUSS COUGH LIQUID EXPECTORANT oral liquid bottle
22. DURO-TUSS PE DRY COUGH LIQUID + NASAL DECONGESTANT oral liquid bottle
23. DIFFLAM PLUS DRY COUGH + ANTIBACTERIAL + ANTI-INFLAMMATORY blackcurrant flavour lozenge blister pack
24. BENADRYL DRY, TICKLY COUGH FORTE pholcodine 4mg/mL oral liquid bottle
25. CODRAL DRY COUGH FORTE STRENGTH pholcodine 4mg/mL oral liquid bottle
26. PRICELINE PHARMACY DRY COUGH RELIEF pholcodine 5mg/5mL oral liquid bottle
27. PHARMACY HEALTH DRY COUGH RELIEF pholcodine 5mg/5mL oral liquid bottle
28. TERRYWHITE CHEMMART DRY COUGH RELIEF pholcodine 1 mg/mL oral liquid bottle
29. TERRYWHITE CHEMMART DRY COUGH FORTE pholcodine 4 mg/ mL oral liquid bottle
30. PHARMACY CHOICE PHOLCODINE DRY FORTE 4mg/mL oral liquid bottle
31. PRICELINE PHARMACY DRY TICKLY COUGH MIXTURE pholcodine 1mg/mL bottle
32. PHARMACY HEALTH DRY TICKLY COUGH MIXTURE pholcodine 1mg/mL bottle
33. SOUL PATTINSON DRY TICKLY COUGH MEDICINE pholcodine 1 mg/mL oral liquid bottle
34. PHARMACY CHOICE DRY COUGH RELIEF FORTE pholcodine 20 mg / 5 mL oral liquid bottle
35. PHARMACY CHOICE DRY COUGH RELIEF pholcodine 5 mg / 5 mL oral liquid bottle
36. TERRYWHITE CHEMMART DRY COUGH RELIEF FORTE pholcodine 20 mg / 5 mL oral liquid bottle
37. NOUMED DRY COUGH LIQUID FORTE pholcodine 4 mg/mL oral liquid bottle
38. NOUMED DRY COUGH LIQUID pholcodine 1 mg/mL oral liquid bottle
39. PHARMACY CHOICE DRY TICKLY COUGH MEDICINE pholcodine 1 mg/mL oral liquid bottle
40. TERRYWHITE CHEMMART DRY COUGH RELIEF pholcodine 5mg/5mL oral liquid bottle
41. AMCAL DRY COUGH FORTE pholcodine 4mg/mL oral liquid bottle
42. AMCAL DRY COUGH MIXTURE pholcodine 1 mg/mL oral liquid bottle
43. PHARMACY HEALTH DRY COUGH RELIEF FORTE pholcodine 4 mg/mL oral liquid bottle
44. PRICELINE PHARMACY DRY COUGH RELIEF FORTE pholcodine 4 mg/mL oral liquid bottle