Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 262476
Summary
The FDA issued a Class II for Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical I by SUN PHARMACEUTICAL INDUSTRIES INC. Reason: Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets..
Details
Source
Drug Recall
External ID
D-0628-2026
Action Date
2026-07-01
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot AE01763, Expires 9/30/2027.
Quantity Affected: 3,456 30-count bottles
Reason for Recall
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-17
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 49 drug recalls issued in the same week, part of 81 drug-related FDA actions this month.
SUN PHARMACEUTICAL INDUSTRIES INC has 85 FDA actions in our database, including 84 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SUN PHARMACEUTICAL INDUSTRIES INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUN PHARMACEUTICAL INDUSTRIES INC have FDA actions?
SUN PHARMACEUTICAL INDUSTRIES INC has 85 FDA actions in our database, including 84 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0628-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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