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CLASS II · ModerateFDA

Ajanta Pharma USA Inc recalls Ranolazine Extended-Release Tablets

📅 Sep 17, 2026 · 📍 Nationwide
Recalling company
Ajanta Pharma USA Inc
Product
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
Failed Dissolution Specifications: below specification
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Sep 17, 2026
Reported
Oct 7, 2026
Distribution
Nationwide in the US.
Status
Ongoing
Lot / codes
Lot: DJ25134, Exp 11/30/2028
Company location
Bridgewater, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0010-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0010-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.