FDA DrugsClass II
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only,...
Published: July 8, 2026Recall ID: D-0656-2026Category: drugsCountry: US
Reason for Recall / Hazard
Subpotent Drug
Product Description & Identification
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15.
Additional Source Details
| Field | Value |
|---|---|
| City | Raleigh |
| State | NC |
| Openfda › Upc › 1 | 0316729447157 |
| Openfda › Upc › 2 | 0316729449151 |
| Openfda › Upc › 3 | 0316729452151 |
| Openfda › Upc › 4 | 0316729454155 |
| Openfda › Upc › 5 | 0316729453158 |
| Openfda › Upc › 6 | 0316729448154 |
| Openfda › Upc › 7 | 0316729451154 |
| Openfda › Upc › 8 | 0316729457156 |
| Openfda › Upc › 9 | 0316729450157 |
| Openfda › Upc › 10 | 0316729456159 |
| Openfda › Upc › 11 | 0316729458153 |
| Openfda › Upc › 12 | 0316729455152 |
| Openfda › Unii | 9J765S329G |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 892246 |
| Openfda › Rxcui › 2 | 892251 |
| Openfda › Rxcui › 3 | 892255 |
| Openfda › Rxcui › 4 | 966220 |
| Openfda › Rxcui › 5 | 966221 |
| Openfda › Rxcui › 6 | 966222 |
| Openfda › Rxcui › 7 | 966224 |
| Openfda › Rxcui › 8 | 966225 |
| Openfda › Rxcui › 9 | 966248 |
| Openfda › Rxcui › 10 | 966249 |
| Openfda › Rxcui › 11 | 966253 |
| Openfda › Rxcui › 12 | 966270 |
| Openfda › Spl id | 415fc774-31a5-124f-e063-6294a90a0e46 |
| Openfda › Brand name | LEVOTHYROXINE SODIUM |
| Openfda › Spl set id | a6233381-3043-4e9a-aaa6-a6b105e5142b |
| Openfda › Package ndc › 1 | 16729-458-15 |
| Openfda › Package ndc › 2 | 16729-458-17 |
| Openfda › Package ndc › 3 | 16729-447-15 |
| Openfda › Package ndc › 4 | 16729-447-17 |
| Openfda › Package ndc › 5 | 16729-448-15 |
| Openfda › Package ndc › 6 | 16729-448-17 |
| Openfda › Package ndc › 7 | 16729-449-15 |
| Openfda › Package ndc › 8 | 16729-449-17 |
| Openfda › Package ndc › 9 | 16729-451-15 |
| Openfda › Package ndc › 10 | 16729-451-17 |
| Openfda › Package ndc › 11 | 16729-450-15 |
| Openfda › Package ndc › 12 | 16729-450-17 |
| Openfda › Package ndc › 13 | 16729-452-15 |
| Openfda › Package ndc › 14 | 16729-452-17 |
| Openfda › Package ndc › 15 | 16729-453-15 |
| Openfda › Package ndc › 16 | 16729-453-17 |
| Openfda › Package ndc › 17 | 16729-454-15 |
| Openfda › Package ndc › 18 | 16729-454-17 |
| Openfda › Package ndc › 19 | 16729-455-15 |
| Openfda › Package ndc › 20 | 16729-455-17 |
| Openfda › Package ndc › 21 | 16729-456-15 |
| Openfda › Package ndc › 22 | 16729-456-17 |
| Openfda › Package ndc › 23 | 16729-457-15 |
| Openfda › Package ndc › 24 | 16729-457-17 |
| Openfda › Product ndc › 1 | 16729-447 |
| Openfda › Product ndc › 2 | 16729-458 |
| Openfda › Product ndc › 3 | 16729-448 |
| Openfda › Product ndc › 4 | 16729-449 |
| Openfda › Product ndc › 5 | 16729-451 |
| Openfda › Product ndc › 6 | 16729-450 |
| Openfda › Product ndc › 7 | 16729-452 |
| Openfda › Product ndc › 8 | 16729-453 |
| Openfda › Product ndc › 9 | 16729-454 |
| Openfda › Product ndc › 10 | 16729-455 |
| Openfda › Product ndc › 11 | 16729-456 |
| Openfda › Product ndc › 12 | 16729-457 |
| Openfda › Generic name | LEVOTHYROXINE SODIUM |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | LEVOTHYROXINE SODIUM |
| Openfda › Manufacturer name | Accord Healthcare Inc. |
| Openfda › Application number | ANDA212399 |
| Openfda › Is original packager | true |
| Event id | 99194 |
| Address 1 | 8041 Arco Corporate Dr Ste 200 |
| Address 2 | N/A |
| Code info | Lot # D2401522, Exp Date: 06/2026. |
| Postal code | 27617-2010 |
| Report date | 20260708 |
| Product type | Drugs |
| Product quantity | 6432 bottles |
| Reason for recall | Subpotent Drug |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260608 |
| Initial firm notification | Letter |
| Center classification date | 20260630 |
Overview
- Recalling FirmACCORD HEALTHCARE, INC.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.