CLASS II ONGOING Drug recall · Reported 7 Oct 2026 · FDA Enforcement Report
Ranolazine Extended-Release Tablets, 1000 mg recalled
Ajanta Pharma USA is recalling Ranolazine Extended-Release Tablets, 1000 mg, distributed nationwide in the US. The recall was initiated on 17 Sep 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0010-2027
- FDA event ID
- 99893
- Recalling firm
- Ajanta Pharma USA, Bridgewater, NJ
- Brand
- Ranolazine
- Manufacturer
- Ajanta Pharma USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Sep 2026
- FDA classified
- 6 Oct 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 17 Sep 2026 | Recall initiated by company | |
| 6 Oct 2026 | Classified by FDA | +19 days |
| 7 Oct 2026 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: below specification
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02
Where it was distributed
Nationwide in the US.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: below specification
Which lots are affected?
Lot: DJ25134, Exp 11/30/2028
Where was it sold?
Nationwide in the US.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ajanta Pharma USA
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fluphenazine Hydrochloride Tablets, USP, 1mg recalledFluphenazine Hydrochloride | Ajanta Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Fenofibrate Capsules, USP 200 mg recalled by Ajanta Pharma USAFenofibrate | Ajanta Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Aripiprazole Tablets recalled by Ajanta Pharma USAAripiprazole | Ajanta Pharma USA | Packaging Defects | Nationwide |
Other Ranolazine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranolazine Extended-Release Tablets 1000mg recalledRanolazine | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ranolazine Extended-Release Tablets 500mg recalledRanolazine | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranolazine ER Tablet, 500 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |