LEVOTHYROXINE SODIUM Recall D-0136-2025
Description: Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-040-20
LEVOTHYROXINE SODIUM Recall D-0136-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0136-2025 |
| Event ID | 95817 |
| Brand | LEVOTHYROXINE SODIUM |
| Generic Name | LEVOTHYROXINE SODIUM |
| Manufacturer | LEVOTHYROXINE SODIUM |
| Active Substance | LEVOTHYROXINE SODIUM |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA. |
| Quantity | 205 cartons |
| Recall Reason | Subpotent and Superpotent Drug |
| Drug Classification | Class II |
| Drug Code Info | 20241218 |
| Product NDC | 42292-038 42292-039 42292-041 |
| Recall Initiation Date | 20241119 |
| Report Date | 20241218 |
| Classification Date | 20241212 |
| Address | 1718 Northrock Ct Rockford, IL 61103-1201 United States |
| Recalling Firm | Mylan Institutional, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 9J765S329G |
| Drug Application Number | ANDA076187 |
| Structured Product Labeling (SPL ID) | 23abca3c-3e7c-a00e-e063-6394a90a41a0 |
| Structured Product Labeling (SPL Set ID) | cd69c192-cd3f-47e6-b0a6-c536ffed5c4b |
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