LEVOTHYROXINE SODIUM

Generic: LEVOTHYROXINE SODIUM ANHYDROUS

Fresenius Kabi USAManufacturer

INTRAVENOUSRoute

LEVOTHYROXINE SODIUM ANHYDROUSActive Substance

2011-06-24Original Approval

LEVOTHYROXINE SODIUM is FDA application NDA202231, sponsored by FRESENIUS KABI USA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2024-11-18

Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles

Superpotent Drug and Subpotent Drug: potency failures obtained

Class II2026-08-06

Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-cou

Subpotent Drug

Class II2026-07-13

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packag

Subpotent Drug

Class II2025-04-10

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., R

Subpotent

Class II2026-07-13

Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Pack

Subpotent Drug

Class II2026-07-13

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Pack

Subpotent Drug

Class II2024-11-18

Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles

Superpotent Drug and Subpotent Drug: potency failures obtained

Class II2026-08-06

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, I

Subpotent Drug

Class II2026-08-06

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,

Subpotent Drug

Class II2025-06-20

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I

Subpotent Drug: Assay below the approved specification

Top Reported Reactions

1

FATIGUE

8,161 reports

2

NAUSEA

7,153 reports

3

DIARRHOEA

6,475 reports

4

HEADACHE

6,274 reports

5

DYSPNOEA

6,210 reports

6

DRUG INEFFECTIVE

5,306 reports

7

PAIN

5,234 reports

8

DIZZINESS

4,994 reports

9

VOMITING

4,485 reports

10

ASTHENIA

4,293 reports