FDA recall D-0010-2027 · Oct 7, 2026
Ajanta Pharma USA Inc: Ranolazine Extended-Release Tablets recall
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 for recall
Failed Dissolution Specifications: below specification
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your package, and look for the company's notice on FDA's recalls page. If you have the product and aren't sure, don't use it until you've checked.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot: DJ25134, Exp 11/30/2028
- Distribution
- Nationwide in the US.
- Recalling firm
- Ajanta Pharma USA Inc, Bridgewater, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-17
Source: openFDA enforcement record D-0010-2027 · search recall number D-0010-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 14, 2026, 12:58 AM EDT. The agency notice is the final word.
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