Levothyroxine Sodium Tablets — Class II drug recall D-0133-2025
Ongoing recall by Mylan Institutional, Inc., reported 2024-12-18, distributed nationwide. Subpotent and Superpotent Drug
| Recall number | D-0133-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional, Inc., Rockford, IL, United States |
| Recall initiated | 2024-11-19 |
| Classified | 2024-12-12 |
| Reported by FDA | 2024-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 1,664 cartons |
| Reason classes | potency |
| NDC | 51079-0440, 51079-0440-01, 51079-0440-20, 51079-0441, 51079-0441-01, 51079-0441-20, 51079-0442, 51079-0442-01, 51079-0442-20, 51079-0443, 51079-0443-01, 51079-0443-20, 51079-0444, 51079-0444-01, 51079-0444-20, 51079-0445, 51079-0445-01, 51079-0445-20 |
| Lot numbers | 3115893 |
| Expiration dates | 2025-06 |
Product
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 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: 51079-443-20
Reason for recall
Subpotent and Superpotent Drug
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0133-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.