Ranolazine Extended-Release Tablets, 1000 mg, 60-count… was recalled on September 17, 2026 in cooperation with the U.S. Food and Drug Administration because failed Dissolution Specifications: below specification.
Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02
Lot: DJ25134, Exp 11/30/2028
Where it was sold: Nationwide in the US.
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Failed Dissolution Specifications: below specification
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Ajanta Pharma USA Inc
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed dissolution specifications.
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