Startseite/Alle Rückrufe/FDA-D-0628-2026
FDA DrugsClass II

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

Veröffentlicht: 1. Juli 2026Rückruf-ID: D-0628-2026Kategorie: Arzneimittel & MedikamenteLand: Vereinigte Staaten
US
PharmaceuticalFDA DrugsUSUS

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 Firm: SUN PHARMACEUTICAL INDUSTRIES INC

🌐
Mitteilung übersetzenTranslate notice text, hazard warnings, and descriptions into any supported language.

Grund für den Rückruf / Gefahr

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

Produktbeschreibung & Identifikation

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

FieldValue
CityPrinceton
StateNJ
Openfda › Nui › 1N0000186106
Openfda › Nui › 2N0000020016
Openfda › Nui › 3N0000191273
Openfda › Nui › 4N0000191278
Openfda › Nui › 5N0000182141
Openfda › Nui › 6N0000187062
Openfda › Upc › 10351672420567
Openfda › Upc › 20351672420666
Openfda › Upc › 30351672420765
Openfda › Upc › 40351672420963
Openfda › Upc › 50351672420468
Openfda › UniiH821664NPK
Openfda › RouteORAL
Openfda › Rxcui › 11356557
Openfda › Rxcui › 21356570
Openfda › Rxcui › 31356574
Openfda › Rxcui › 41356578
Openfda › Rxcui › 51356582
Openfda › Rxcui › 61356586
Openfda › Spl id4653e298-d84f-dc92-e063-6294a90a2d75
Openfda › Brand namePERAMPANEL
Openfda › Spl set id1b0458ea-e718-4d48-ae55-ad9b4d863810
Openfda › Package ndc › 151672-4205-6
Openfda › Package ndc › 251672-4205-2
Openfda › Package ndc › 351672-4204-6
Openfda › Package ndc › 451672-4204-3
Openfda › Package ndc › 551672-4206-6
Openfda › Package ndc › 651672-4206-2
Openfda › Package ndc › 751672-4207-6
Openfda › Package ndc › 851672-4207-2
Openfda › Package ndc › 951672-4208-6
Openfda › Package ndc › 1051672-4208-2
Openfda › Package ndc › 1151672-4209-6
Openfda › Package ndc › 1251672-4209-2
Openfda › Product ndc › 151672-4204
Openfda › Product ndc › 251672-4205
Openfda › Product ndc › 351672-4206
Openfda › Product ndc › 451672-4207
Openfda › Product ndc › 551672-4208
Openfda › Product ndc › 651672-4209
Openfda › Generic namePERAMPANEL
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Substance namePERAMPANEL
Openfda › Pharm class epcNoncompetitive AMPA Glutamate Receptor Antagonist [EPC]
Openfda › Pharm class moa › 1AMPA Receptor Antagonists [MoA]
Openfda › Pharm class moa › 2UGT2B7 Inhibitors [MoA]
Openfda › Pharm class moa › 3UGT1A9 Inhibitors [MoA]
Openfda › Pharm class moa › 4Cytochrome P450 3A4 Inhibitors [MoA]
Openfda › Pharm class moa › 5Cytochrome P450 2C8 Inhibitors [MoA]
Openfda › Manufacturer nameSun Pharmaceutical Industries, Inc.
Openfda › Application numberANDA209538
Openfda › Is original packagertrue
Event id99256
Address 12 Independence Way
Address 2N/A
Code infoLot AE01763, Expires 9/30/2027.
Postal code08540-6620
Report date20260701
Product typeDrugs
Product quantity3,456 30-count bottles
Reason for recallLabeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260617
Initial firm notificationLetter
Center classification date20260626

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 262...?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Übersicht

  • Rückrufendes UnternehmenSUN PHARMACEUTICAL INDUSTRIES INC
  • StatusOngoing
  • RisikostufeClass II
  • DistributionNationwide in the USA
Recall Hazard Severity
High Alert (Class I)
Offizielle Behördenwarnung

📢 Warnung teilen

Alert family and friends to keep them safe. Copy this quick alert message:

🚨 SAFETY ALERT: SUN PHARMACEUTICAL INDUSTRIES INC - 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

Check if your household is affected:
https://therecallfile.com/de/recalls/perampanel-ciii-tablets-6mg-rx-only-30-tablets-mfd-by-taro-pharmaceuti/FDA-D-0628-2026
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