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FDAFDA · Food and drugs·Recall number D-0010-2027

Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02

Published October 7, 2026 · Recall initiated: September 17, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Failed Dissolution Specifications: below specification

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
RANOLAZINE
Manufacturer
Ajanta Pharma USA Inc
Distributor
Nationwide in the US.
UPC
0327241125027
Lot
Lot: DJ25134, Exp 11/30/2028
Risk classification
Class II
Area (FDA)
drug
Country
United States

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Questions about this recall

Was Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02 recalled?

Yes. FDA published recall D-0010-2027 on October 7, 2026. Reported hazard: Failed Dissolution Specifications: below specification

What should I do if I have this product?

Voluntary: Firm initiated · Letter

How do I know if my unit is part of the recall?

Compare your product details with the notice. Brand: RANOLAZINE. UPC: 0327241125027.

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