Perampanel CIII Tablets recall
FDA recall D-0628-2026 · initiated Jun 17, 2026
SUN PHARMACEUTICAL INDUSTRIES INC recalled Perampanel CIII Tablets in Jun 2026 — an FDA Class II recall (D-0628-2026) because Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3,456 30-count bottles
Details
- 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
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jun 17, 2026
- FDA report date
- Jul 1, 2026
Frequently asked
- Was Perampanel CIII Tablets recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Perampanel CIII Tablets in Jun 2026 — an FDA Class II recall (D-0628-2026) because Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Perampanel CIII Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0628-2026 was: Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
- Is a recalled Perampanel CIII Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Perampanel CIII Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot AE01763, Expires 9/30/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0628-2026.