Levothyroxine Sodium Tablets — Class II drug recall D-0526-2021
Terminated recall by Cardinal Health Inc., reported 2021-06-02, distributed in FL, GA, SC. CGMP Deviations: Intermittent exposure to temperature excursion during storage.
| Recall number | D-0526-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2021-03-15 |
| Classified | 2021-05-24 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2024-06-17 |
| Distributed | FL, GA, SC |
| Quantity | 112 bottles |
| Reason classes | cgmp, temperature control |
| NDC | 00378-1800, 00378-1800-10, 00378-1800-77, 00378-1803, 00378-1803-10, 00378-1803-77, 00378-1805, 00378-1805-10, 00378-1805-77, 00378-1807, 00378-1807-10, 00378-1807-77, 00378-1809, 00378-1809-10, 00378-1809-77, 00378-1811, 00378-1811-10, 00378-1811-77, 00378-1813, 00378-1813-10, 00378-1813-77, 00378-1815, 00378-1815-10, 00378-1815-77, 00378-1817 and 10 more |
Product
Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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-0526-2021. 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.