Ranolazine Recall: Ajanta Pharma USA 1000 mg Extended-Release
Announced 2026-10-07 · FDA
The FDA is recalling Ranolazine Extended-Release Tablets, 1000 mg, 60-count Rx bottles distributed nationwide in the United States, due to failed dissolution specifications (below specification). The affected lot is DJ25134, expiring 11/30/2028.
| Brand | 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 |
| Severity | moderate |
| Distribution | Nationwide in the US. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any remaining tablets from Lot DJ25134.
- Contact your pharmacist or healthcare provider for guidance and disposal instructions.
- Return the product to the place of purchase for a refund or replacement if applicable.
How to identify the recalled item
| Lot / date codes | Lot: DJ25134, Exp 11/30/2028 |
|---|---|
| Lot / date codes | Lot: DJ25134, Exp 11/30/2028 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.