Aurobindo Pharma recalls 400mg Rufinamide Tablets due to manufacturing quality issues
Aurobindo Pharma USA Inc. recalls 400mg Rufinamide Tablets (120-count) due to cGMP deviations in batch production. This recall follows release of the batch before regulatory approval. No specific action steps are listed in the official notice.
Recall notice
cGMP deviations: Batch was released prior to approval.
Contact the company
What happened, in plain English
Aurobindo Pharma is recalling 400mg Rufinamide Tablets in 120-count bottles that were manufactured in India and distributed in the U.S. The recall is due to quality control issues where the batch was released before receiving regulatory approval. Read more at govinfonow.com/recall/33234-aurobindo-pharma-recalls-400mg-rufinamide-tablets-due-to-manufacturing-quality.
Source Summary by GovInfoNow · govinfonow.com/recall/33234-aurobindo-pharma-recalls-400mg-rufinamide-tablets-due-to-manufacturing-quality · Updated August 17, 2026 · FDA enforcement record: FDA #D-1088-2023
Cite this page
“Aurobindo Pharma recalls 400mg Rufinamide Tablets due to manufacturing quality issues.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33234-aurobindo-pharma-recalls-400mg-rufinamide-tablets-due-to-manufacturing-quality. Based on FDA recall #D-1088-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1088-2023%22&limit=1).
Why it’s dangerous
The batch of Rufinamide Tablets was released by the manufacturer before it received regulatory approval, which could mean the product does not meet safety standards. This cGMP (current Good Manufacturing Practice) deviation may lead to potential quality issues that could affect patient safety.
Who’s affected
Prescription patients who have received the recalled 400mg Rufinamide Tablets in 120-count bottles. Patients using this medication for seizure disorders are most at risk due to the potential for quality issues.
How to tell if you have this one
Look for Rufinamide Tablets, USP 400 mg in 120-count bottles with the lot number RB4023002A and expiration date 02/2025. The product is distributed by Aurobindo Pharma USA Inc. in the U.S.
- Brand
Aurobindo Pharma- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
USA nationwide- NDC
59651-616-08, 59651-617-08
| Recall number | Product, codes & lots |
|---|---|
| D-1087-2023 | Rufinamide Tablets, USP 200 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 59651-616-08; Lot #: RB2023001A, Exp 02/2025 |
| D-1088-2023 | 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; Lot #: RB4023002A, Exp 02/2025 |
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the packaging to determine if the product is recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1088-2023 (July 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1088-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.