Ranolazine Extended-Release Tablets 1000 mg Recall: Failed Dissolution
Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Ranolazine Extended-Release Tablets 1000 mg recalled?
Failed Dissolution Specifications: below specification
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
Lot: DJ25134, Exp 11/30/2028
- Agency record number
- D-0010-2027
- 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
- Recalling firm
- Ajanta Pharma USA Inc
- Distribution
- Nationwide in the US.
- Recall started
- September 17, 2026
- Report date
- October 7, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)