Alphapharm Pty Ltd t/as Mylan Australia — DILART® and DILART®HCT (Valsartan) Tablets

PRA number


Published date

Product description

Valsartan is used for the treatment of hypertension and heart failure in patients.

DILART® valsartan 40mg film-coated tablets (AUST R 167425)
DILART® valsartan 80mg film-coated tablets (AUST R 167427)
DILART® valsartan 160mg film-coated tablets (AUST R 167426)
DILART® valsartan 320mg film-coated tablets (AUST R 167421)

DILART® HCT 80/12.5mg valsartan 80mg/hydrochlorothiazide 12.5mg film-coated tablets (AUST R 187397)
DILART® HCT 160/12.5mg valsartan 160mg/hydrochlorothiazide 12.5mg film-coated tablets (AUST R 187403)
DILART® HCT 160/25mg valsartan 160mg/hydrochlorothiazide 25mg film-coated tablets (AUST R 187400)
DILART® HCT 320/12.5mg valsartan 320mg/hydrochlorothiazide 12.5mg film-coated tablets (AUST R 187402)
DILART® HCT 320/25mg valsartan 320mg/hydrochlorothiazide 25mg film-coated tablets (AUST R 187399)

The following batches of Valsartan film coated tablets (DILART®):
40mg - 8058886 (expiry Mar-20); 8063916 (expiry Apr-20); 8065072 (expiry Jun-20); 8070855 (expiry Oct-20)
80mg - 8045929 (expiry Jan-19); 8063786 (expiry Apr-20); 8063762 (expiry Apr-20); 8061781 (expiry Feb-20); 8061781 (expiry May-20)
160mg - 8045896 (expiry Mar-19); 8055982 (expiry Jan-20); 8064559 (expiry Jan-20); 8062862 (expiry Mar-20)
320mg - 8045924 (expiry Mar-19); 8048002 (expiry Mar-19); 8059368 (expiry Mar-20); 8059896 (expiry Mar-20); 8063761 (expiry Mar-20);
8070229 (expiry Mar-20); 8073700 (expiry Apr-20)

The following batches of Valsartan/ Hydrochlorothiazide film coated tablets (DILART® HCT):
80/12.5 mg - 8038886 (expiry Aug-19); 8076887 (expiry Mar-21)
160/12.5 mg - 8044826 (expiry Aug-19); 8076373 (expiry Mar-21)
160/25 mg - 8047518 (expiry Aug-19); 8075463 (expiry Mar-21)
320/12.5 mg - 8044825 (expiry Aug-19); 8075198 (expiry Mar-21)
320/25 mg - 8042677 (expiry Aug-19); 8075228 (expiry Mar-21)
Identifying features

Other identifying numbers

Batch Numbers and Expiry Dates as described in the Product Description above

Reasons the product is recalled

An impurity, N-nitrosodiethylamine (NDEA) has been found in batches of Valsartan.

The hazards to consumers

NDEA has been classified as a probable human carcinogen.

What consumers should do

Patients are asked to return any DILART® or DILART® HCT to the supplying pharmacy for a refund and to discuss replacement options.

Patients who are on DILART® or DILART® HCT should NOT stop taking their medication prior to consulting a health care professional, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.
Pharmacists have been advised that patients should be offered an alternative brand or referred to their health care professional if an alternative treatment is required. 

Patients have been advised NOT to cease their medication without seeking advice from their health care professional.  

For further information please contact customer service on 1800 274 276.

Where the product was sold


Dates available for sale


Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category

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