BPOM Regulation No. 12 of 2026 Strengthens the Recall and Destruction Mechanism for Non-Compliant Medicinal Products and Drug Substances

Introduction

On 30 June 2026, the Indonesian Food and Drug Authority ("BPOM") issued BPOM Regulation No. 12 of 2026 on the Recall and Destruction of Medicinal Products and/or Drug Substances that Do Not Meet the Standards and/or Requirements for Safety, Efficacy, Quality, Labelling, and/or Product Information ("BPOM Regulation No. 12 of 2026"), which took effect on 9 July 2026.

BPOM Regulation No. 12 of 2026 establishes the latest regulatory framework governing the recall and destruction of medicinal products and drug substances that fail to comply with the applicable standards and requirements relating to safety, efficacy, quality, labelling, and product information. It revokes and supersedes BPOM Regulation No. 14 of 2022 on the Recall and Destruction of Medicinal Products that Do Not Meet the Standards and/or Requirements for Safety, Efficacy, Quality, and Labelling ("BPOM Regulation No. 14 of 2022"), as the previous regulation did not adequately address several categories of substandard medicinal products identified in the market. 

Through BPOM Regulation No. 12 of 2026, BPOM strengthens its regulatory oversight to provide greater protection to public health by introducing provisions governing the recall and destruction of drug substances, expanding the scope of supervision to include product information, and establishing new requirements for vaccines that do not possess a Batch Release Certificate. Compared with BPOM Regulation No. 14 of 2022, the new regulation primarily expands the scope of regulated objects, introduces stricter requirements for vaccines, and broadens the scope of product recalls.

Comparison

The following table highlights the principal differences between BPOM Regulation No. 12 of 2026 and BPOM Regulation No. 14 of 2022: 

Key Provisions 

Recall and Destruction Obligations

Pursuant to Article 2, marketing authorisation holders are required to recall medicinal products that are found not to comply with the applicable requirements relating to safety, efficacy, quality, labelling, and/or product information.

Furthermore, Article 24 requires marketing authorisation holders to destroy not only the finished medicinal products concerned, but also any associated packaging, labels, defective drug substances, and any remaining inventory under their control.

The destruction process must be witnessed by BPOM officials, and its completion must be reported electronically together with supporting documentation in the form of photographs and/or videos evidencing the destruction. Nevertheless, BPOM Regulation No. 12 of 2026 does not yet specify in detail the procedures, reporting mechanism, or electronic platform to be used for submitting such reports.

Risk-Based Recall Classification

Articles 9 and 10 classify recalls into the following three risk categories:

Risk-Based Drug Recall Classification

Reporting Deadlines and Scope of Recall 

Article 19 requires marketing authorisation holders to submit an Initial Report to BPOM promptly after a recall instruction has been issued. The Initial Report must be submitted within:

• 24 hours for a Class I Recall;
• 5 (five) days for a Class II Recall; and
• 10 (ten) days for a Class III Recall.

calculated from the date on which the recall instruction is issued.

In addition, the recall must cover the entire distribution and use chain of the medicinal product, including distribution facilities, pharmaceutical service facilities (including pharmacies and hospitals), retail stores, independent medical practices, and products that have already reached consumers.

Public Disclosure Obligations

Pursuant to Article 18, marketing authorisation holders are required to publicly disclose information concerning the implementation of a recall as part of their transparency obligations.

The published information must include:

• the identity of the recalled non-compliant medicinal product;
• the affected Batch/Lot number;
• the reasons for the recall together with an explanation of the associated risks;
• the scope of the recall; and
• guidance for members of the public, medical practitioners, and healthcare professionals who discover, possess, or have consumed the recalled medicinal product.

Administrative Sanctions 

Pursuant to Article 28, BPOM may impose administrative sanctions on marketing authorisation holders that fail to comply with their obligations under BPOM Regulation No. 12 of 2026, including failure to conduct a recall, late submission of reports, failure to disclose recall information to the public, or failure to destroy non-compliant products.

Administrative sanctions are imposed progressively according to the severity of the violation, ranging from written warnings and final warnings to the temporary suspension of manufacturing activities, suspension of marketing authorisations, and ultimately the revocation of marketing authorisations or Emergency Use Authorisations (EUAs).

Transitional Provision 

Pursuant to Article 30, all recall and destruction activities involving medicinal products or drug substances that commenced and remained ongoing before the entry into force of BPOM Regulation No. 12 of 2026 on 9 July 2026 shall remain valid and continue to be governed by BPOM Regulation No. 14 of 2022.

Closing

BPOM Regulation No. 12 of 2026 significantly strengthens Indonesia's regulatory framework governing the recall and destruction of medicinal products and drug substances that fail to comply with applicable standards and regulatory requirements. Compared with BPOM Regulation No. 14 of 2022, the new regulation broadens the scope of regulated objects, imposes more stringent requirements for vaccine products, expands the scope of recall implementation, and reinforces the obligations of marketing authorisation holders with respect to reporting, public disclosure, and the destruction of non-compliant products.

For pharmaceutical companies and other businesses operating within the pharmaceutical sector, BPOM Regulation No. 12 of 2026 requires enhanced compliance with quality management systems and post-market surveillance obligations, including maintaining the capability to conduct product recalls promptly, transparently, and in a properly documented manner based on BPOM's risk-based classification system. Given that non-compliance may result in administrative sanctions, including the suspension or revocation of marketing authorisations or Emergency Use Authorisations (EUAs), marketing authorisation holders should review and update their internal procedures governing product recalls, reporting, destruction, and public communications to ensure full compliance with BPOM Regulation No. 12 of 2026, thereby mitigating legal risks while safeguarding public health.