Class II · ModerateActive recall
Ranolazine
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot: DJ25134, Exp 11/30/2028
Where it was soldNationwide in the US.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Dissolution Specifications: below specification
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAjanta Pharma USA Inc.
| Brand name | RANOLAZINE |
| Generic name | RANOLAZINE |
| Active ingredient(s) | RANOLAZINE |
| Distributed by / for | Ajanta Pharma USA Inc |
| NDC | 27241-126-02 |
Show the full FDA record
| Full product label | 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 initiated | 2026-09-17 |
| Report date | 2026-10-07 |
| Recall completed | — |
| Recall number | D-0010-2027 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Bridgewater NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.