BPOM Tightens Drug Recall and Destruction Requirements: Wider Reach Extends to Retailers and Research Institutions

The Head of the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan– “ BPOM ”) has issued Regulation No. 12 of 2026 on the Recall and Destruction of Drugs and/or Drug Materials That Do Not Meet Standards and/or Requirements for Safety, Efficacy, Quality, Labeling and/or Product Information (“ Regulation 12/2026 ”). The issuance of Regulation 12/2026 has simultaneously revoked Regulation of the BPOM No. 14 of 2022 (“ Regulation 14/2022 ”), which addressed similar matters. [1]