CLASS II Drug recall · Reported 30 Aug 2023 · FDA Enforcement Report
Rufinamide Tablets, USP 400 mg recalled by Aurobindo Pharma USA
Aurobindo Pharma USA is recalling Rufinamide Tablets, USP 400 mg, distributed nationwide in the US. The recall was initiated on 21 Jul 2023 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-1088-2023
- FDA event ID
- 92756
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Brand
- Rufinamide
- Manufacturer
- Aurobindo Pharma Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jul 2023
- FDA classified
- 18 Aug 2023
- Reported
- 30 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 21 Jul 2023 | Recall initiated by company | |
| 18 Aug 2023 | Classified by FDA | +28 days |
| 30 Aug 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations: Batch was released prior to approval.
Product as listed by the FDA
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08
Where it was distributed
USA nationwide
Questions about this recall
Why was it recalled?
cGMP deviations: Batch was released prior to approval.
Which lots are affected?
Lot #: RB4023002A, Exp 02/2025
Where was it sold?
USA nationwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 92756| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rufinamide Tablets, USP 200 mg recalled by Aurobindo Pharma USARufinamide | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Aurobindo Pharma USA
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
Other Rufinamide recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rufinamide Tablets 200mg recalled by Glenmark PharmaceuticalsRufinamide | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Rufinamide Tablets, USP 200 mg recalled by Aurobindo Pharma USARufinamide | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Banzel (rufinamide) tablets 200 mg recalled by Cardinal HealthBanzel | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |