Levothyroxine Sodium Tablets — Class II drug recall D-0291-2025
Ongoing recall by Mylan Institutional, Inc., reported 2025-03-26, distributed nationwide. Super-Potent Drug: Out of specification potency results were obtained.
| Recall number | D-0291-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional, Inc., Rockford, IL, United States |
| Recall initiated | 2025-03-07 |
| Classified | 2025-03-20 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,068 cartons |
| Reason classes | potency, specification failure |
| 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 | 3115773 |
| Expiration dates | 2025-03-31 |
Product
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.
Reason for recall
Super-Potent Drug: Out of specification potency results were obtained.
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-0291-2025. 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.