Inicio/Ver Todos los Retiros/FDA-D-0770-2026
FDA DrugsClass II

Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.

Publicado: 26 de agosto de 2026ID de Retiro: D-0770-2026Categoría: Medicamentos y FármacosPaís: Estados Unidos
US
PharmaceuticalFDA DrugsUSUS

Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.

Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC

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Traducir AvisoTranslate notice text, hazard warnings, and descriptions into any supported language.

Motivo del Retiro / Peligro

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Descripción del Producto e Identificación

Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.

Additional Source Details

FieldValue
CityPrinceton
StateNJ
Openfda › Nui › 1N0000008486
Openfda › Nui › 2N0000175751
Openfda › Nui › 3N0000185506
Openfda › Nui › 4N0000191266
Openfda › Nui › 5N0000187064
Openfda › Nui › 6N0000185507
Openfda › Nui › 7N0000185607
Openfda › Upc › 10351672405014
Openfda › Upc › 20351672412418
Openfda › Upc › 30351672404741
Openfda › Unii33CM23913M
Openfda › RouteORAL
Openfda › Rxcui › 1197442
Openfda › Rxcui › 2199378
Openfda › Rxcui › 3308973
Openfda › Rxcui › 4308976
Openfda › Rxcui › 5308979
Openfda › Rxcui › 6402505
Openfda › Rxcui › 7402506
Openfda › Spl id48fd19fc-5d5b-0d24-e063-6294a90a0aa0
Openfda › Brand nameCARBAMAZEPINE
Openfda › Spl set id0526a054-3eda-49b4-b390-7d5d16e30af8
Openfda › Package ndc › 151672-4041-1
Openfda › Package ndc › 251672-4041-2
Openfda › Package ndc › 351672-4041-9
Openfda › Package ndc › 451672-4041-0
Openfda › Package ndc › 551672-4050-1
Openfda › Package ndc › 651672-4005-1
Openfda › Package ndc › 751672-4005-2
Openfda › Package ndc › 851672-4005-3
Openfda › Package ndc › 951672-4123-6
Openfda › Package ndc › 1051672-4123-1
Openfda › Package ndc › 1151672-4123-3
Openfda › Package ndc › 1251672-4124-6
Openfda › Package ndc › 1351672-4124-1
Openfda › Package ndc › 1451672-4124-3
Openfda › Package ndc › 1551672-4125-6
Openfda › Package ndc › 1651672-4125-1
Openfda › Package ndc › 1751672-4125-3
Openfda › Package ndc › 1851672-4047-9
Openfda › Package ndc › 1951672-4047-4
Openfda › Product ndc › 151672-4005
Openfda › Product ndc › 251672-4041
Openfda › Product ndc › 351672-4050
Openfda › Product ndc › 451672-4123
Openfda › Product ndc › 551672-4124
Openfda › Product ndc › 651672-4125
Openfda › Product ndc › 751672-4047
Openfda › Generic nameCARBAMAZEPINE
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Pharm class peDecreased Central Nervous System Disorganized Electrical Activity [PE]
Openfda › Substance nameCARBAMAZEPINE
Openfda › Pharm class epcMood Stabilizer [EPC]
Openfda › Pharm class moa › 1Cytochrome P450 3A4 Inducers [MoA]
Openfda › Pharm class moa › 2Cytochrome P450 1A2 Inducers [MoA]
Openfda › Pharm class moa › 3Cytochrome P450 2B6 Inducers [MoA]
Openfda › Pharm class moa › 4Cytochrome P450 2C9 Inducers [MoA]
Openfda › Pharm class moa › 5Cytochrome P450 2C19 Inducers [MoA]
Openfda › Manufacturer nameSun Pharmaceutical Industries, Inc.
Openfda › Application numberANDA074649
Openfda › Is original packagertrue
Event id99562
Address 12 Independence Way
Code infoLot # AD94033, Exp Date: 5/31/2028.
Postal code08540-6620
Report date20260826
Product typeDrugs
Product quantity1968 Bottles (1000Tablets/Bottle)
Reason for recallCGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260803
Initial firm notificationLetter
Center classification date20260818

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 Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd.,...?

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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Resumen

  • Empresa ResponsableSUN PHARMACEUTICAL INDUSTRIES INC
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionUS Nationwide.
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: SUN PHARMACEUTICAL INDUSTRIES INC - Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.

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Spread the WordCarbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.

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