Three Medicine Safety Updates — 14 August 2026

PharmExpert’s daily pharmacovigilance monitoring identified three significant medicine safety updates.

Tyenne (tocilizumab-aazg): batch recall due to glass particles

The FDA announced a nationwide recall of one batch of Tyenne® (tocilizumab-aazg) injection 400 mg/20 mL: lot 16UI07, expiry 08/2028, NDC 65219-594-20. The recall follows the detection of glass particles in vials.

Administration of a particle-containing product may cause irritation, pain, swelling and phlebitis. If particles enter the bloodstream, possible consequences include vascular occlusion, thrombosis, embolism, organ damage and, in severe cases, death. Healthcare facilities should stop using the affected lot and return the product.

Importance: high. This is a quality defect with a documented patient-safety risk and a medicine recall.

Official source: FDA.

pms-IRBESARTAN: possible presence of tablets containing hydrochlorothiazide

Health Canada published a Type II recall notice for lot 667278 of pms-IRBESARTAN 150 mg (ID RA-82479). Packages may contain pms-IRBESARTAN/HCTZ 150/12.5 mg tablets, creating a risk of unintended exposure to hydrochlorothiazide.

Patients should check the lot number, should not stop treatment on their own, and should contact a healthcare professional or pharmacist. The affected product should be returned to a pharmacy.

Importance: medium. A medicine mix-up may expose patients to an additional active substance that was not prescribed.

Official source: Health Canada.

CellCept (mycophenolate mofetil): post-treatment contraception extended to six months

Singapore’s HSA announced that the contraception period for women of childbearing potential after stopping CellCept® has been extended from six weeks to six months. The update takes account of genotoxic potential, drug elimination and oocyte maturation.

Mycophenolate is associated with an increased risk of pregnancy loss and congenital malformations. Two reliable methods of contraception are recommended before treatment, throughout therapy and for six months after treatment ends. Product information and risk-minimisation materials will be updated.

Importance: high. The regulator established a new duration for a measure intended to minimise teratogenic risk.

Official source: HSA Singapore.

This article is based on official regulatory information and does not replace medical advice or the approved product information.