Ajanta Pharma USA Inc recall D-0010-2027 · FDA Recalls

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Class IIDrugOngoing

Ajanta Pharma USA Inc

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

Reason for recall

Failed Dissolution Specifications: below specification

Details

Recall number: D-0010-2027
Event ID: 99893
Recall initiated: Sep 17, 2026
Classified: Oct 6, 2026
Reported: Oct 7, 2026
Distribution: Nationwide in the US.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Bridgewater, NJ, United States
Lot / code info: Lot: DJ25134, Exp 11/30/2028