Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61
USLevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61
Recalling Firm: Major Pharmaceuticals
Reason for Recall / Hazard
Subpotent Drug
Product Description & Identification
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61
Affected Products
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61
Additional Source Details
| Field | Value |
|---|---|
| City | Dublin |
| State | OH |
| Openfda › Unii | 9J765S329G |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 892246 |
| Openfda › Rxcui › 2 | 966220 |
| Openfda › Rxcui › 3 | 966221 |
| Openfda › Rxcui › 4 | 966222 |
| Openfda › Rxcui › 5 | 966224 |
| Openfda › Rxcui › 6 | 966225 |
| Openfda › Rxcui › 7 | 966248 |
| Openfda › Rxcui › 8 | 966249 |
| Openfda › Rxcui › 9 | 966253 |
| Openfda › Spl id | 942c00a3-b31c-48d5-a63d-6d394645ee1f |
| Openfda › Brand name | LEVOTHYROXINE SODIUM |
| Openfda › Spl set id | 333642fd-93ae-4dc0-9c83-6d6b163c1c74 |
| Openfda › Package ndc › 1 | 0904-6949-61 |
| Openfda › Package ndc › 2 | 0904-6950-61 |
| Openfda › Package ndc › 3 | 0904-6951-61 |
| Openfda › Package ndc › 4 | 0904-6952-61 |
| Openfda › Package ndc › 5 | 0904-6953-61 |
| Openfda › Package ndc › 6 | 0904-6954-61 |
| Openfda › Package ndc › 7 | 0904-6955-61 |
| Openfda › Package ndc › 8 | 0904-6956-61 |
| Openfda › Package ndc › 9 | 0904-6957-61 |
| Openfda › Product ndc › 1 | 0904-6949 |
| Openfda › Product ndc › 2 | 0904-6950 |
| Openfda › Product ndc › 3 | 0904-6951 |
| Openfda › Product ndc › 4 | 0904-6952 |
| Openfda › Product ndc › 5 | 0904-6953 |
| Openfda › Product ndc › 6 | 0904-6954 |
| Openfda › Product ndc › 7 | 0904-6955 |
| Openfda › Product ndc › 8 | 0904-6956 |
| Openfda › Product ndc › 9 | 0904-6957 |
| Openfda › Generic name | LEVOTHYROXINE SODIUM |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | LEVOTHYROXINE SODIUM |
| Openfda › Manufacturer name | Major Pharmaceuticals |
| Openfda › Application number | ANDA209713 |
| Openfda › Original packager product ndc › 1 | 68180-965 |
| Openfda › Original packager product ndc › 2 | 68180-966 |
| Openfda › Original packager product ndc › 3 | 68180-967 |
| Openfda › Original packager product ndc › 4 | 68180-968 |
| Openfda › Original packager product ndc › 5 | 68180-969 |
| Openfda › Original packager product ndc › 6 | 68180-970 |
| Openfda › Original packager product ndc › 7 | 68180-971 |
| Openfda › Original packager product ndc › 8 | 68180-973 |
| Openfda › Original packager product ndc › 9 | 68180-974 |
| Event id | 99399 |
| Address 1 | 7000 Cardinal Pl |
| Address 2 | N/A |
| Code info | Lot# N02172, exp 07/2026; N02296, N02288, Exp. Date 12/2026 |
| Postal code | 43017-1091 |
| Report date | 20260729 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | Subpotent Drug |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260713 |
| Initial firm notification | Letter |
| Center classification date | 20260717 |
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Overview
- Recalling FirmMajor Pharmaceuticals
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA.
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🚨 SAFETY ALERT: Major Pharmaceuticals - Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61 Check if your household is affected: https://therecallfile.com/recalls/levothyroxine-sodium-tablets-usp-75-mcg-0-075-mg-100-tablets-10-x-10-u/FDA-D-0702-2026
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