ArticleTherapeutic advances in drug safety2025
Drug recall, its frequencies and conclusion: a retrospective secondary analysis involving 2-year publicly available data from Nepal.
Article in Therapeutic advances in drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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 in greater frequencies among all the recall notices. Most recalls were made from domestic pharmaceutical companies (84%). The majority of the drugs (34%) were recalled after 15 months of the finished product being in the market, whereas only 26% were recalled within the first 5 months. Conclusion: A robust and continuous evaluation of drug recalls by regulatory authorities can help reduce their frequency, lessen their impact on the healthcare system, and improve overall drug safety.
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