Ranolazine Extended-Release Tablets recall (Ajanta Pharma USA Inc)
DrugClass IIOngoing
Summary: Ajanta Pharma USA Inc is recalling 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.
What is being recalled
Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02
Why
Failed Dissolution Specifications: below specification
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the US.
How to tell if yours is affected
Lot: DJ25134, Exp 11/30/2028
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0010-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 17, 2026 |
| Reported | October 7, 2026 |
| Company | Ajanta Pharma USA Inc |
| Company location | Bridgewater, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
More recalls from Ajanta Pharma USA Inc · all drug recalls · recalls from September 2026