Seven medicine safety updates — 8 September 2026

The PharmExpert daily review highlights seven significant regulatory updates from Russia, Singapore, Australia and the European Union.

1. Metoprolol retard-Akrikhin: batch recall

Roszdravnadzor reported the voluntary recall of batch 1870625 of Metoprolol retard-Akrikhin 50 mg because it failed the dissolution specification. Letter No. 02I-1027/26.

Official Roszdravnadzor notice

2. Indapamide: microbiological purity

Batch 301025 of Indapamide 2.5 mg is being recalled because it did not comply with microbiological purity requirements. Letter No. 02I-1028/26 continues measures initiated in August 2026.

Official Roszdravnadzor notice

3. Phthisopyram: batch recall

AKRIKHIN is recalling batch 450724 of Phthisopyram 150 mg + 500 mg following a failure of the dissolution specification. Letter No. 02I-1029/26.

Official Roszdravnadzor notice

4. Simethicone: batch removed from circulation

Roszdravnadzor terminated circulation of batch 181025 of Simethicone 40 mg because of non-compliance with the packaging specification. Letter No. 02I-1026/26 is dated 4 September and appeared as a separate card on 7 September.

Official Roszdravnadzor notice

5. Singapore: dangerous Dermcare weight product

HSA warned about Dermcare weight (D30 & Sstrong Set), marketed as a natural weight-loss product. Testing detected banned sibutramine and undeclared amiloride, hydrochlorothiazide, fluoxetine, orlistat and bisacodyl. These substances can cause serious cardiovascular and other adverse reactions.

HSA safety alert

6. Australia: Deep Heat Extra Strength recall

TGA announced an urgent recall of Deep Heat Extra Strength 100 g Cream, batches V772 and V773, expiry 06/2029. The product may be contaminated with Pluralibacter gergoviae, which can cause serious infection, particularly on broken skin or in immunocompromised people.

TGA market action

7. EMA: methotrexate and epidermal necrosis

Following PSUSA/00002014/202510, PRAC and CHMP concluded that a causal relationship between methotrexate and epidermal necrosis is at least a reasonable possibility. Product information, including for Jylamvo and Nordimet, should be updated. The benefit-risk balance remains unchanged subject to these changes.

EMA scientific conclusions

What pharmaceutical companies should do

Marketing-authorisation holders, distributors and pharmacovigilance professionals should assess affected products and batches, verify local corrective actions and ensure timely implementation of safety-information updates.

Prepared by PharmExpert from official regulator communications published on 7–8 September 2026.