Ajanta Pharma Ranolazine Extended-Release Tablets
Ranolazine Extended-Release Tablets fail dissolution specifications.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Ajanta Pharma USA Inc. recalled Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, marketed by Ajanta Pharma USA Inc., Bridgewater, NJ 08807, because the product failed dissolution specifications. The recall began September 17, 2026, and was added to the FDA's Enforcement Report on September 25, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
Ranolazine Extended-Release Tablets
- NDC
- 27241-126-02
- Lot
- DJ25134
Details
- Company began the recall
- Sold in
Nationwide in the US.
- Event ID
- 99893
- Recall No.
- D-0010-2027
- Company
- Ajanta Pharma USA IncBridgewater, New Jersey
- Hazard
- Dissolution failure
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
Classified by FDA
In FDA's weekly enforcement report
