Ranolazine Tablets Recalled Due to Failed Dissolution Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for ranolazine extended-release tablets, 1000 mg. The affected batch has been identified as Lot DJ25134 (expires November 2028).
• The recall was initiated by Ajanta Pharma USA, Inc due to the product’s failure to meet dissolution specifications, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Ranolazine is used to treat chronic angina.

The FDA has issued a Class II recall for ranolazine extended-release tablets, 1000 mg. This product is being recalled by Ajanta Pharma USA, Inc based in Bridgewater, New Jersey. The recall was initiated on September 17, 2026, and received a Class II classification on October 6, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated after the product failed to meet dissolution specifications. This issue affects Lot DJ25134, which will expire in November 2028. Ajanta Pharma USA sent out a public notice via letter; no press release was issued for this recall.

Ranolazine is a prescription medication used to treat chronic angina. Pharmacists should identify and quarantine Lot DJ25134, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. October 7, 2026. Accessed October 7, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222834