On November 24, 2025, the U.S. Food and Drug Administration (FDA) approved VKT Pharma's reformulated ranitidine tablets in 150 mg and 300 mg strengths. Following extensive safety testing and manufacturing improvements, this marks the return of the acid-reducing medication to the U.S. market after a five-year absence.
In 2020, the FDA requested the immediate withdrawal of all prescription and over-the-counter (OTC) ranitidine drugs (commonly known as brand name Zantac) from the market due to concerns about an N-nitrosodimethylamine (NDMA) impurity formation during the product’s shelf-life.
The 2025 ranitidine formulation maintains the same therapeutic effectiveness as previously approved products and patients currently using alternative H2 blockers or proton pump inhibitors should consult their healthcare providers before switching medications.
The newly reformulated products will include updated labeling with strict storage and handling instructions for the safe and effective use of the product which include:
- Keep ranitidine Tablets in the original container (bottle) and protect them 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.
As always, patients should consult with their healthcare providers about the best treatment options for their individual needs.
MyMatrixx Actions
Ulcer medications, like ranitidine, make up a low percentage of the MyMatrixx book of business, and are typically prescribed to counteract the gastrointestinal effects from non-steroidal anti-inflammatory medications (NSAIDs). The MyMatrixx clinical team will continue to monitor the trajectory of this reformulation and its use with our clients and patients.