Sun Pharmaceutical Perampanel 6mg Tablets Recall: Label Mix-Up Risk
Sun Pharmaceutical recalls Perampanel CIII 6mg tablets due to label mix-up with 10mg tablets. Affected units contain incorrect labeling that may lead to incorrect dosing.
Lower-risk recall
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
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What happened, in plain English
Sun Pharmaceutical is recalling Perampanel CIII 6mg tablets because some bottles were mislabeled with 10mg tablets instead of 6mg. This mix-up could lead to incorrect dosing if the wrong tablet is taken. Read more at govinfonow.com/recall/31195-sun-pharmaceutical-perampanel-6mg-tablets-recall-label-mix-up-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31195-sun-pharmaceutical-perampanel-6mg-tablets-recall-label-mix-up-risk · Updated August 10, 2026 · FDA enforcement record: FDA #D-0628-2026
Cite this page
“Sun Pharmaceutical Perampanel 6mg Tablets Recall: Label Mix-Up Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31195-sun-pharmaceutical-perampanel-6mg-tablets-recall-label-mix-up-risk. Based on FDA recall #D-0628-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0628-2026%22&limit=1).
Why it’s dangerous
The recall involves a mislabeling issue where some bottles of Perampanel CIII 6mg tablets were incorrectly labeled as 10mg tablets. This could lead to incorrect dosing if the wrong tablet is taken by a patient.
Who’s affected
People with prescriptions for Perampanel CIII 6mg tablets who received this specific batch from Sun Pharmaceutical. Those with the incorrect labeling are at risk of taking the wrong dose.
How to tell if you have this one
Check for bottles labeled 'Perampanel 6 mg tablets' with the NDC code 51672-4206-6 and lot number AE01763. The product was manufactured by Taro Pharmaceutical Industries Ltd. in Haifa Bay, Israel.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Label
Verify the label on the bottle matches the correct dosage of 6mg Perampanel CIII tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 14 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product dangerous if taken incorrectly?
The recall is due to a label mix-up, not an immediate safety hazard. Taking the wrong tablet could lead to incorrect dosing, but the product itself is not harmful if used correctly.
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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-0628-2026 (June 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0628-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.