FDA DrugsClass II
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical I...
Published: July 1, 2026Recall ID: D-0628-2026Category: drugsCountry: US
Reason for Recall / Hazard
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Openfda › Nui › 1 | N0000186106 |
| Openfda › Nui › 2 | N0000020016 |
| Openfda › Nui › 3 | N0000191273 |
| Openfda › Nui › 4 | N0000191278 |
| Openfda › Nui › 5 | N0000182141 |
| Openfda › Nui › 6 | N0000187062 |
| Openfda › Upc › 1 | 0351672420567 |
| Openfda › Upc › 2 | 0351672420666 |
| Openfda › Upc › 3 | 0351672420765 |
| Openfda › Upc › 4 | 0351672420963 |
| Openfda › Upc › 5 | 0351672420468 |
| Openfda › Unii | H821664NPK |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 1356557 |
| Openfda › Rxcui › 2 | 1356570 |
| Openfda › Rxcui › 3 | 1356574 |
| Openfda › Rxcui › 4 | 1356578 |
| Openfda › Rxcui › 5 | 1356582 |
| Openfda › Rxcui › 6 | 1356586 |
| Openfda › Spl id | 4653e298-d84f-dc92-e063-6294a90a2d75 |
| Openfda › Brand name | PERAMPANEL |
| Openfda › Spl set id | 1b0458ea-e718-4d48-ae55-ad9b4d863810 |
| Openfda › Package ndc › 1 | 51672-4205-6 |
| Openfda › Package ndc › 2 | 51672-4205-2 |
| Openfda › Package ndc › 3 | 51672-4204-6 |
| Openfda › Package ndc › 4 | 51672-4204-3 |
| Openfda › Package ndc › 5 | 51672-4206-6 |
| Openfda › Package ndc › 6 | 51672-4206-2 |
| Openfda › Package ndc › 7 | 51672-4207-6 |
| Openfda › Package ndc › 8 | 51672-4207-2 |
| Openfda › Package ndc › 9 | 51672-4208-6 |
| Openfda › Package ndc › 10 | 51672-4208-2 |
| Openfda › Package ndc › 11 | 51672-4209-6 |
| Openfda › Package ndc › 12 | 51672-4209-2 |
| Openfda › Product ndc › 1 | 51672-4204 |
| Openfda › Product ndc › 2 | 51672-4205 |
| Openfda › Product ndc › 3 | 51672-4206 |
| Openfda › Product ndc › 4 | 51672-4207 |
| Openfda › Product ndc › 5 | 51672-4208 |
| Openfda › Product ndc › 6 | 51672-4209 |
| Openfda › Generic name | PERAMPANEL |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | PERAMPANEL |
| Openfda › Pharm class epc | Noncompetitive AMPA Glutamate Receptor Antagonist [EPC] |
| Openfda › Pharm class moa › 1 | AMPA Receptor Antagonists [MoA] |
| Openfda › Pharm class moa › 2 | UGT2B7 Inhibitors [MoA] |
| Openfda › Pharm class moa › 3 | UGT1A9 Inhibitors [MoA] |
| Openfda › Pharm class moa › 4 | Cytochrome P450 3A4 Inhibitors [MoA] |
| Openfda › Pharm class moa › 5 | Cytochrome P450 2C8 Inhibitors [MoA] |
| Openfda › Manufacturer name | Sun Pharmaceutical Industries, Inc. |
| Openfda › Application number | ANDA209538 |
| Openfda › Is original packager | true |
| Event id | 99256 |
| Address 1 | 2 Independence Way |
| Address 2 | N/A |
| Code info | Lot AE01763, Expires 9/30/2027. |
| Postal code | 08540-6620 |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260617 |
| Initial firm notification | Letter |
| Center classification date | 20260626 |
Overview
- Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA