Four medicine safety updates — 15 August 2026

On 15 August 2026, PharmExpert identified four high-importance official safety updates: three medicine recalls in Russia for quality defects and one recall in France due to a potential double dose of temozolomide.

Ketorolac: recall of batch 170924

PJSC Sintez is recalling batch 170924 of Ketorolac 30 mg/ml solution for intravenous and intramuscular injection because it failed the impurities specification. Roszdravnadzor letter No. 01I-940/26 is dated 12 August 2026.

Official notice · Official letter (PDF)

Iopromide TR: visible particulate matter

MOSPHARM is recalling batch 0010126 of Iopromide TR 370 mg iodine/ml, 100 ml solution for injection. The stated failures concern appearance and visible mechanical inclusions. Visible particles in an injectable medicine have direct patient-safety relevance.

Official notice · Official letter (PDF)

Omnipaque 350: urgent recall of six batches

Batches 17277315, 17312303, 17323704, 17370063, 17407055 and 17425028 of Omnipaque 350 mg iodine/ml, 100 ml are being urgently recalled because particles may be present in polypropylene vials. If a particle detaches and is not detected before intravenous administration, it may pose a risk to the patient. No complaints or adverse-reaction reports had been received when the manufacturer issued the notice.

Official notice · Official letter (PDF)

Temozolomide Accord 250 mg: double-dose risk

ANSM announced the recall of batch P2600019 after two capsules were found in a sachet intended to contain one. The packaging error may cause a double dose of this cytotoxic medicine and a haematological risk. Patients are instructed to return affected packs and, if an overdose has occurred, seek emergency care for haematological assessment.

Official ANSM notice

Pharmacovigilance implications

Organisations should check their stock for the affected batches, implement the recalls and communicate the information to healthcare professionals. Particular attention is warranted for parenteral products with visible or potential particles and for the temozolomide overdose risk.

This article is based on official regulator communications available on 15 August 2026.