Five medicine quality recalls and restrictions — 19 August 2026

Roszdravnadzor has published five new notices concerning medicine quality defects. All five cards appeared on 18 August 2026 after the previous pharmacovigilance monitoring checkpoint. The actions affect specific batches of ketorolac, rifampicin, linezolid, troxerutin and calcium gluconate.

Key updates

1. Ketorolac, batch 190425

Circulation of Ketorolac 30 mg/mL solution for intravenous and intramuscular injection, manufactured by Sintez PJSC, has been discontinued. The batch failed the specification for impurities and is to be withdrawn and destroyed.

Importance: high. The quality defect affects an injectable medicine and the regulator explicitly requires action to eliminate a threat to life and health.

Roszdravnadzor notice No. 01I-949/26 · official letter (PDF)

2. Rifampicin-Ferein®, batch 191123

Circulation of the 150 mg lyophilisate for solution for injection, manufactured by Bryntsalov-A JSC, has been discontinued. The batch failed specifications for dissolution time, clarity, mechanical inclusions, related impurities and abnormal toxicity. Withdrawal and destruction are required.

Importance: critical. The combination of defects, including mechanical inclusions and abnormal toxicity, creates a direct patient-safety concern.

Roszdravnadzor notice No. 01I-950/26 · official letter (PDF)

3. Linezolid, batch 0150526

Linezolid 2 mg/mL solution for infusion, manufactured by MOSPHARM LLC, failed the bacterial endotoxins specification. Roszdravnadzor requires measures to eliminate the resulting threat to life and health.

Importance: critical. Bacterial endotoxins in a parenteral antibiotic may present a serious risk to patients.

Roszdravnadzor notice No. 01I-951/26 · official letter (PDF)

4. TROXERUTIN VELPHARM, batch 10224

The manufacturer is recalling 300 mg capsules because the batch failed the dissolution specification. The new notice formalises the batch recall following the previously identified defect.

Importance: medium. A dissolution failure may affect release of the active substance and therapeutic effectiveness.

Roszdravnadzor notice No. 01I-952/26 · official letter (PDF)

5. Calcium gluconate, batch 840924

Armavir Biofactory is recalling calcium gluconate 100 mg/mL solution for intravenous and intramuscular injection because the batch failed the description specification. The letter continues the earlier regulatory action and confirms the recall of the affected batch.

Importance: high. The action concerns a parenteral medicine and is intended to remove a potential patient-safety risk.

Roszdravnadzor notice No. 01I-953/26 · official letter (PDF)

What organisations and patients should consider

Organisations involved in the medicine supply chain should verify product names, strengths and batch numbers against the official letters and complete the required withdrawal measures. Patients should not stop prescribed treatment without professional advice. Anyone holding a product from an affected batch should contact their pharmacy or treating healthcare professional for instructions.

This update is based on official Roszdravnadzor notices published on 18 August 2026.