FDA Drug recall D-0526-2021
Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc
- FDA Drug
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc by Cardinal Health, citing CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0526-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-15 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | FL, GA, SC |
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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Identifiers
| ndc | 0378-1800-77 |
|---|---|
| ndc | 0378-1800-10 |
| ndc | 0378-1803-77 |
| ndc | 0378-1803-10 |
| ndc | 0378-1805-77 |
| ndc | 0378-1805-10 |
| ndc | 0378-1807-77 |
| ndc | 0378-1807-10 |
| ndc | 0378-1809-77 |
| ndc | 0378-1809-10 |
| ndc | 0378-1811-77 |
| ndc | 0378-1811-10 |
| ndc | 0378-1813-77 |
| ndc | 0378-1813-10 |
| ndc | 0378-1823-77 |
| ndc | 0378-1823-10 |
| ndc | 0378-1815-77 |
| ndc | 0378-1815-10 |
| ndc | 0378-1817-77 |
| ndc | 0378-1817-10 |
| ndc | 0378-1819-77 |
| ndc | 0378-1819-10 |
| ndc | 0378-1821-77 |
| code_info | 3109046 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0526-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.