Home/Recalls/FDA-D-0707-2026
FDA DrugsClass II

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61

Published: July 29, 2026Recall ID: D-0707-2026Category: drugsCountry: US
US
PharmaceuticalFDA DrugsUSUS

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61

Recalling Firm: Major Pharmaceuticals

Reason for Recall / Hazard

Subpotent Drug

Product Description & Identification

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61

Additional Source Details

FieldValue
CityDublin
StateOH
Openfda › Upc0055154356305
Openfda › Unii9J765S329G
Openfda › RouteORAL
Openfda › Rxcui › 1892246
Openfda › Rxcui › 2966220
Openfda › Rxcui › 3966221
Openfda › Rxcui › 4966222
Openfda › Rxcui › 5966224
Openfda › Rxcui › 6966225
Openfda › Rxcui › 7966253
Openfda › Rxcui › 8966248
Openfda › Rxcui › 9966249
Openfda › Spl id › 11708f9ee-1578-432d-8d8c-e8192dd53b52
Openfda › Spl id › 2942c00a3-b31c-48d5-a63d-6d394645ee1f
Openfda › Brand nameLEVOTHYROXINE SODIUM
Openfda › Spl set id › 131a31756-68aa-4e01-bbb1-9d181f8d9181
Openfda › Spl set id › 2333642fd-93ae-4dc0-9c83-6d6b163c1c74
Openfda › Package ndc › 155154-3558-0
Openfda › Package ndc › 255154-3559-0
Openfda › Package ndc › 355154-3560-0
Openfda › Package ndc › 455154-4309-0
Openfda › Package ndc › 555154-3561-0
Openfda › Package ndc › 655154-3562-0
Openfda › Package ndc › 755154-3563-0
Openfda › Package ndc › 80904-6949-61
Openfda › Package ndc › 90904-6950-61
Openfda › Package ndc › 100904-6951-61
Openfda › Package ndc › 110904-6952-61
Openfda › Package ndc › 120904-6953-61
Openfda › Package ndc › 130904-6954-61
Openfda › Package ndc › 140904-6955-61
Openfda › Package ndc › 150904-6956-61
Openfda › Package ndc › 160904-6957-61
Openfda › Product ndc › 155154-3558
Openfda › Product ndc › 255154-3559
Openfda › Product ndc › 355154-3560
Openfda › Product ndc › 455154-4309
Openfda › Product ndc › 555154-3561
Openfda › Product ndc › 655154-3562
Openfda › Product ndc › 755154-3563
Openfda › Product ndc › 80904-6949
Openfda › Product ndc › 90904-6950
Openfda › Product ndc › 100904-6951
Openfda › Product ndc › 110904-6952
Openfda › Product ndc › 120904-6953
Openfda › Product ndc › 130904-6954
Openfda › Product ndc › 140904-6955
Openfda › Product ndc › 150904-6956
Openfda › Product ndc › 160904-6957
Openfda › Generic nameLEVOTHYROXINE SODIUM
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Substance nameLEVOTHYROXINE SODIUM
Openfda › Manufacturer name › 1Cardinal Health 107, LLC
Openfda › Manufacturer name › 2Major Pharmaceuticals
Openfda › Application numberANDA209713
Openfda › Original packager product ndc › 10904-6949
Openfda › Original packager product ndc › 20904-6950
Openfda › Original packager product ndc › 30904-6951
Openfda › Original packager product ndc › 40904-6952
Openfda › Original packager product ndc › 50904-6953
Openfda › Original packager product ndc › 60904-6955
Openfda › Original packager product ndc › 70904-6956
Openfda › Original packager product ndc › 868180-965
Openfda › Original packager product ndc › 968180-966
Openfda › Original packager product ndc › 1068180-967
Openfda › Original packager product ndc › 1168180-968
Openfda › Original packager product ndc › 1268180-969
Openfda › Original packager product ndc › 1368180-970
Openfda › Original packager product ndc › 1468180-971
Openfda › Original packager product ndc › 1568180-973
Openfda › Original packager product ndc › 1668180-974
Event id99399
Address 17000 Cardinal Pl
Address 2N/A
Code infoBag lot #: N02212A, N02212B, Exp. Date 07/2026; Blister lot #: N02212, Exp. Date 07/2026
Postal code43017-1091
Report date20260729
Product typeDrugs
Product quantityN/A
Reason for recallSubpotent Drug
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260713
Initial firm notificationLetter
Center classification date20260717

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Overview

  • Recalling FirmMajor Pharmaceuticals
  • StatusOngoing
  • Risk LevelClass II
  • DistributionNationwide in the USA.
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: Major Pharmaceuticals - Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61

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Spread the WordLevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61

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