FDA recall, , Moderate risk
Sun Pharmaceutical Perampanel CIII Tablets
Perampanel CIII Tablets, 6mg, may contain a 10mg tablet due to a label mix-up.
Summary by Recall Canary from the FDA notice
What happened
Sun Pharmaceutical Industries Inc. of Princeton, New Jersey, recalled Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, after a 10mg Perampanel CIII tablet was found in a bottle labeled Perampanel 6 mg tablets.
The product, manufactured by Taro Pharmaceutical Industries Ltd. in Haifa Bay, Israel, and distributed by Sun Pharmaceutical Industries Inc. in Cranbury, NJ, was distributed nationwide in the USA. The recall began on June 17, 2026, and was added to the FDA's Enforcement Report on June 24, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Perampanel CIII Tablets, 6mg
- NDC
- 51672-4206-6
- Lot code
- AE01763
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- SUN PHARMACEUTICAL INDUSTRIES INCPrinceton, New Jersey
- Hazard
- Labeling error
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99256
- Recall number
- D-0628-2026
All recalls from SUN PHARMACEUTICAL INDUSTRIES INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
Classified by FDA
In FDA's weekly enforcement report
Summary updated
