Ranitidine Hydrochloride

November 24, 2025 -- Today, the U.S. Food and Drug Administration approved reformulated ranitidine tablets, marking the return of this important acid-reducing medication to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that address previous concerns about N-nitrosodimethylamine (NDMA) impurity formation during the product’s shelf-life. Ranitidine, an H2 receptor antagonist, is widely used to treat conditions including gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Clinical Considerations: Healthcare providers and patients should be aware that the reformulated ranitidine maintains the same therapeutic effectiveness as previously approved products. Patients currently using alternative H2 blockers or proton pump inhibitors should consult their healthcare providers before switching medications. Approved products will include updated labeling with storage and handling instructions. Patients and healthcare providers should consider the new storage conditions for the safe and effective use of the product which include: Keep Ranitidine Tablets in the original container (bottle) and protect from moisture. After the first opening of the bottle, discard unused tablets after 3 months (90 days), or by the expiration date on the bottle, whichever is sooner. If more than one bottle is dispensed, open only one bottle at a time. Store additional bottles without opening until needed for dosing. At the time of dosing, remove one tablet from the bottle. Immediately close the bottle, secure the cap, and keep the bottle tightly closed. Keep the desiccant in the bottle. Source: FDA

New Delhi: Amid the renewed scrutiny of popular antacid ‘Ranitidine’, following the recommendation by the top drug advisory board, India’s apex regulator has directed the country's drugmakers to monitor the levels of NDMA in the API and formulation of the drug. Issuing a directive to state drug controllers, the Drugs Controller General of India (DCGI) ordered the regulators “to direct the manufacturers under their jurisdiction to monitor the NDMA levels in the API/formulation of Ranitidine and also take risk-based measures such as reducing the shelf life, etc.” The directive has been issued following the recommendation by the Drug Technical Advisory Board , which had proposed, “the manufacturers should monitor the NDMA levels in the APl/formulation and also take risk based measures such as reducing the shelf life etc.” Ranitidine is a popular small molecule indicated for the treatment of indigestion, heartburn, acid reflux etc and is marketed by a number of MNC and domestic companies in India under their respective brand names. However, the drug has been linked to health concerns, including cancer risks, due to the presence of NDMA (N-Nitrosodimethylamine) at levels exceeding acceptable limits. Notably, the directive issued by the apex regulator notes that, “the issue related to safety of Ranitidine drug due to presence of NDMA impurity has been under consideration for quite some time. Following an investigation, in April 2020, the US FDA had ordered the withdrawal of all Over-The Counter (OTC) and prescription ranitidine products from the country’s market due to the exceeding levels of NDMA. Under its investigation the US regulator had determined that the impurity (NDMA) in some ranitidine products “increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.” In India, after reviewing the report of an expert committee formed by the CDSCO in December 2024, at its 92nd meeting, DTAB members recommended to constitute a larger committee “which will look into all the aspects including the storage conditions of the drug.” Additionally, the top advisory board had also proposed an lCMR-executed study for assessing the safety of the drug considering the presence of NDMA impurity. By Abhijeet Singh ,