Drug recall, its frequencies and conclusion: a retrospective secondary analysis involving 2-year publicly available data from Nepal
Abstract
Background: Drug recalls safeguard patients from potentially harmful existing pharmaceutical products in the market due to safety concerns or manufacturing issues.
Objective: To analyze the drug recall patterns, frequencies, and causes based on the publicly available data from the Nepalese Drug Regulatory Authority, Department of Drug Administration (DDA).
Design: A 2-year retrospective secondary analysis was conducted based on drug recalls in Nepal, which is available from the official website of DDA, Nepal.
Methods: The substandard drug recalls data from April 17th, 2023 to May 14th, 2025 were included in the study from which information were extracted across various domains, including the drug name, dosage forms, manufacturing and expiry date, reasons for the recall, and recall date whereas, inclusion of falsified medicines and information regarding the "special permission," "news & updates," and "notices" sections within the DDA website were excluded from the studies to ensure only drug recalls were incorporated.
Results: The study showed that 50 recalls were made over the 2 year period. The majority of the recalled drugs were antibiotics (16%). The most common reasons for drug recalls were assay failure (34%) and non-compliance with standards set out by the Indian Pharmacopoeia-2022 (40%), followed by United States Pharmacopoeia-2022 (28%). Oral formulations (74%) were most commonly recalled, out of which tablets (32%), suspensions (16%), and syrups (12%) were recalled…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
Read the paper
Related studies
- Artificial Intelligence in Medicine: Cross-Sectional Study Among Medical Students on Application, Education, and Ethical Aspects
- Information quality of videos related to esophageal cancer on tiktok, kwai, and bilibili: a cross-sectional study
- The quality and reliability of short videos about hypertension on TikTok: a cross-sectional study
- Quality and reliability evaluation of pancreatic cancer-related video content on social short video platforms: a cross-sectional study
- Quality and reliability of pediatric pneumonia related short videos on mainstream platforms: cross-sectional study
- Association between metabolic score for insulin resistance (METS-IR) and hypertension: a cross-sectional study based on NHANES 2007–2018
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.