Quick answers
- What is Tirosint?
- Tirosint is a brand name of Levothyroxine, a prescription medicine. The FDA NDC Directory lists 15 Tirosint products in 15 strengths and forms.
- Who makes Tirosint?
- Ibsa holds the FDA application for Tirosint (NDA021924, approved October 13, 2006).
- Is there a generic or store brand of Tirosint?
- Yes. The FDA NDC Directory lists 12 other products with the same active ingredients, strength and form as a Tirosint product, 12 of them generic. Ask your pharmacist whether one is right for you.
- Has Tirosint been recalled?
- FDA enforcement reports list 1 recall of Tirosint products; the newest started March 15, 2021. A recall usually concerns specific lots, not every product.
What Tirosint is
Each Tirosint product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Levothyroxine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| levothyroxine sodium 100 ug capsule (oral) | Tirosint | 1 product, 1 company | DailyMed |
| levothyroxine sodium 112 ug capsule (oral) | Tirosint | 1 product, 1 company | DailyMed |
| levothyroxine sodium 125 ug capsule (oral) | Tirosint | 1 product, 1 company | DailyMed |
| levothyroxine sodium 13 ug capsule (oral) | Tirosint | 1 product, 1 company | DailyMed |
| levothyroxine sodium 137 ug capsule (oral) | Tirosint | 1 product, 1 company | DailyMed |
| levothyroxine sodium 150 ug capsule (oral) | Tirosint | 1 product, 1 company | DailyMed |
| levothyroxine sodium 175 ug capsule (oral) | Tirosint | 1 product, 1 company | DailyMed |
| levothyroxine sodium 200 ug capsule (oral) | Tirosint | 1 product, 1 company | DailyMed |
| levothyroxine sodium 25 ug capsule (oral) | Tirosint | 1 product, 1 company | DailyMed |
| levothyroxine sodium 37.5 ug capsule (oral) | Tirosint | None listed | DailyMed |
| levothyroxine sodium 44 ug capsule (oral) | Tirosint | None listed | DailyMed |
| levothyroxine sodium 50 ug capsule (oral) | Tirosint | 1 product, 1 company | DailyMed |
| levothyroxine sodium 62.5 ug capsule (oral) | Tirosint | None listed | DailyMed |
| levothyroxine sodium 75 ug capsule (oral) | Tirosint | 1 product, 1 company | DailyMed |
| levothyroxine sodium 88 ug capsule (oral) | Tirosint | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Levothyroxine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021924 | Ibsa | October 13, 2006 | 15 |
Companies that list Tirosint
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tirosint products.
- IBSA Pharma Inc.15 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 15, 2021 · Class II · Terminated · D-0495-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES — Cardinal Health Inc.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.