FDA Drug recall D-0495-2021
TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules
- FDA Drug
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules 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-0495-2021 |
| 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
TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES
Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Identifiers
| ndc | 71858-0013-4 |
|---|---|
| ndc | 71858-0013-1 |
| ndc | 71858-0013-2 |
| ndc | 71858-0012-4 |
| ndc | 71858-0012-1 |
| ndc | 71858-0012-2 |
| ndc | 71858-0005-4 |
| ndc | 71858-0005-1 |
| ndc | 71858-0005-2 |
| ndc | 71858-0010-4 |
| ndc | 71858-0010-1 |
| ndc | 71858-0010-2 |
| ndc | 71858-0015-4 |
| ndc | 71858-0015-1 |
| ndc | 71858-0015-2 |
| ndc | 71858-0020-4 |
| ndc | 71858-0020-1 |
| ndc | 71858-0020-2 |
| ndc | 71858-0025-4 |
| ndc | 71858-0025-1 |
| ndc | 71858-0025-2 |
| ndc | 71858-0030-4 |
| ndc | 71858-0030-1 |
| ndc | 71858-0030-2 |
| ndc | 71858-0035-4 |
| ndc | 71858-0035-1 |
| ndc | 71858-0035-2 |
| ndc | 71858-0040-4 |
| ndc | 71858-0040-1 |
| ndc | 71858-0040-2 |
| ndc | 71858-0045-4 |
| ndc | 71858-0045-1 |
| ndc | 71858-0045-2 |
| ndc | 71858-0050-4 |
| ndc | 71858-0050-1 |
| ndc | 71858-0050-2 |
| ndc | 71858-0055-4 |
| ndc | 71858-0055-1 |
| ndc | 71858-0055-2 |
| ndc | 71858-0060-4 |
| ndc | 71858-0060-1 |
| ndc | 71858-0060-2 |
| ndc | 71858-0017-4 |
| ndc | 71858-0017-1 |
| ndc | 71858-0017-2 |
| code_info | 200606 |
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-0495-2021%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.