Drug Recalls Rise in 2025: Quality Concerns & GMP Inspections

Quality Concerns Rise in Pharmaceutical Manufacturing

Concerns regarding the quality of pharmaceutical products continue to surface globally, with a notable increase in recalls and disposals reported in recent years. While 2025 saw a slight decrease in the total number of incidents compared to 2024, the figures remain significantly higher than in 2023, signaling ongoing challenges in maintaining pharmaceutical quality control.

According to data released by the Ministry of Food and Drug Safety on February 8, 2026, a total of 296 drug recalls and disposals were recorded in 2025. This represents a roughly 14% decrease from the 343 cases reported in 2024, but a 16% increase compared to the 256 cases documented in 2023. These figures underscore the fluctuating, yet persistently elevated, level of quality-related issues within the pharmaceutical industry.

Leading Companies Involved in Recalls

Mirae Bio Pharmaceuticals led the list of companies with the highest number of recalls in 2025, with 29 cases. The primary reasons cited for these actions were concerns about the overall quality of distributed products (16 cases) and quality nonconformity (12 cases). Specifically, a product named ‘Bowihwangjeong’ was found to be of inadequate quality following a disintegration test and was subsequently recalled.

Hwanin Pharmaceutical followed closely behind with 14 recall cases, largely attributed to the detection of impurities exceeding acceptable standards. NtabHub experienced 12 recalls due to a variety of issues, including the presence of heavy metals – specifically sulfur dioxide, lead, and cadmium – residual pesticides, and problems with quantitative methods. Over the past two years, NtabHub has faced a total of 22 recall and disposal orders, with 10 occurring in 2024 alone.

Hyunjin Pharmaceutical also faced significant scrutiny, with 14 recalls in 2024 and an additional 7 recall/disposal orders in 2025, totaling 21 over the two-year period. Taegeukin Agricultural Corporation reported seven recall cases in 2025. In contrast, CK, which had 11 recalls in 2024, saw a decrease to 6 cases in 2025.

Regulatory Response and Oversight

The increasing number of recalls has prompted heightened scrutiny from regulatory bodies. An official from the Ministry of Food and Drug Safety stated that when recalls or disposals are necessitated by poor quality control, administrative measures will be taken following thorough inspections of Good Manufacturing Practice (GMP) and Quality Management systems. This suggests a move towards stricter enforcement of quality standards and increased accountability for pharmaceutical manufacturers.

Global Implications and Increased Scrutiny

These developments occur within a broader context of growing global concern regarding pharmaceutical quality. Recent reports highlight increasing scrutiny of drug manufacturers, particularly those based in India, following a series of recalls and quality issues. This has led regulators worldwide to tighten oversight of pharmaceutical production and distribution.

The FDA has also reported a significant uptick in drug quality inspections since the pandemic, indicating a renewed focus on ensuring the safety and efficacy of medications. This increased inspection activity is likely a response to concerns about potential compromises in quality control during the disruptions caused by the pandemic.

Infant Formula Concerns

The issue of pharmaceutical quality extends to infant formula, as evidenced by an outbreak investigation of infant botulism linked to contaminated formula in November 2025. This outbreak underscores the critical importance of rigorous quality control measures in the production of infant formula, given the vulnerability of this population.

The Need for Enhanced Quality Control

The recent surge in pharmaceutical recalls and quality concerns highlights the need for enhanced quality control measures throughout the entire pharmaceutical supply chain. This includes stricter adherence to GMP guidelines, more frequent and thorough inspections, and improved detection methods for identifying impurities and quality defects. The focus must be on preventing these issues from occurring in the first place, rather than simply reacting to them after they have already impacted patients.

The ongoing scrutiny from regulatory agencies and the increasing awareness of quality issues among the public are likely to drive further improvements in pharmaceutical manufacturing practices. However, sustained vigilance and a commitment to quality at all levels of the industry are essential to ensure the safety and efficacy of medications for patients worldwide.

The Ministry of Food and Drug Safety’s commitment to administrative measures following GMP inspections signals a proactive approach to addressing quality deficiencies. Continued investment in regulatory oversight and a collaborative effort between manufacturers, regulators, and healthcare professionals will be crucial in safeguarding public health and maintaining trust in the pharmaceutical industry.