FDA Drugs recall ·

Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets… recall

Recall number
D-0628-2026
Date
(initiated June 17, 2026)
Company / brand
Sun Pharmaceutical Industries Inc
2 Independence Way, Princeton, NJ, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
3,456 30-count bottles
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

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

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot AE01763, Expires 9/30/2027.

Distribution

Nationwide in the USA

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0628-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.