FDAClass IIRecall started June 17, 2026

Perampanel CIII Tablets 6 mg Recall: Labeling Error

Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun…

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was Perampanel CIII Tablets 6 mg recalled?

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6

Which lot codes, UPCs or models are affected?

Lot AE01763, Expires 9/30/2027.

Agency record number
D-0628-2026
Product
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun…
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Quantity
3,456 30-count bottles
Distribution
Nationwide in the USA
Recall started
June 17, 2026
Report date
July 1, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls