Five medicine safety updates — 28 August 2026

PharmExpert’s daily review of official pharmacovigilance sources identified four new medicine-safety actions and one corrective recall notice.

Russia: Vaseline oil batch withdrawn for density non-compliance

Roszdravnadzor published Information Letter No. 01I-1009/26 on 27 August 2026 concerning Vaseline oil, oral oil 100 ml, batch 50522, manufactured by Flora Kavkaza JSC.

The batch was classified as substandard because it failed the “Density” specification. Roszdravnadzor ordered its circulation to cease, instructed the batch holder to withdraw and destroy affected stock, and explicitly required action to eliminate a threat of harm to life and health.

Official Roszdravnadzor notice · Official PDF

Canada: Apo-Semaglutide dose display and delivery defect

Health Canada published a Type II retail recall for Apo-Semaglutide 2 mg/pen, semaglutide 0.68 mg/ml, DIN 02568020, lot 700059A (RA-82536).

The dose window may display 2 mg and the device may deliver 2 mg instead of the expected 0.25 mg or 0.5 mg dose. Patients were advised to check their product and consult a healthcare professional before stopping treatment.

Official Health Canada recall

Canada: Dr. Reddy’s semaglutide recalled for an out-of-specification impurity

Health Canada published a Type II retail recall for Semaglutide Injection 1.34 mg/ml supplied by Dr. Reddy’s Laboratories Canada Inc. (RA-82537). The affected products are DIN 02567806, lots 7000544–7000546, and DIN 02567814, lots 7000542, 7000543, 7000624, 7000628 and 7000629.

The recall was initiated because of an out-of-specification impurity in all affected lots. Patients were advised not to discontinue treatment without consulting a healthcare professional and to report adverse reactions.

Official Health Canada recall

Brazil: falsified Dysport 500U batch ordered seized

Anvisa published Resolution 3,356/2026 concerning Dysport 500U (botulinum toxin), lot P22686 (COMP-007736). The marketing authorisation holder, Beaufour Ipsen Farmacêutica, reported that the batch had never been imported by the company and that its labelling did not match the genuine product.

Anvisa ordered the falsified batch to be seized.

Official Anvisa notice

Singapore: Carbimazole 5 Tablet Class 2 recall

Singapore’s Health Sciences Authority published a wholesale-level Class 2 recall of Carbimazole 5 Tablet 5 mg, registration SIN06923P, covering 11 batches: 118605, 116385, 116384, 112792, 112791, 109399, 109358, 101671, 101666, 98210 and 97872.

The recall followed out-of-specification stability-study results. HSA defines Class 2 recalls as involving defects that could cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. Wholesalers and distributors were instructed to stop supply and return remaining stock.

Official HSA recall

Why this matters

These actions cover a defective dose-delivery device, impurity and stability failures, a falsified botulinum-toxin product and a substandard oral medicine batch. Marketing authorisation holders, distributors and healthcare organisations should identify affected stock promptly and follow the relevant regulator’s instructions.

This summary is based on official regulator publications and does not replace approved product information or local clinical guidance.