Quick answers
- What is Liothyronine sodium used for?
- The FDA-approved label (Cytomel, Pfizer Laboratories Div Pfizer Inc, May 18, 2026) says: “CYTOMEL is an L-triiodothyronine (T3) indicated for: • Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism • Pituitary Thyroid-Stimulating Hormone (TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer • Thyroid Suppression Test …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Liothyronine sodium have a boxed warning?
- Yes. The FDA label for Cytomel has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Liothyronine sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Liothyronine sodium been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started December 4, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Liothyronine sodium?
- 19 companies list prescription products of Liothyronine sodium in the FDA NDC Directory, including Sigmapharm Laboratories, LLC, Bryant Ranch Prepack and Teva Pharmaceuticals USA, Inc..
What Liothyronine sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CYTOMEL is an L-triiodothyronine (T3) indicated for: • Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism • Pituitary Thyroid-Stimulating Hormone (TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer • Thyroid Suppression Test …
— FDA label: Cytomel, Pfizer Laboratories Div Pfizer Inc, effective May 18, 2026. Read the full label on DailyMed →
The FDA has 27 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
27 of 27 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| liothyronine sodium 25 ug tablet | Generic | $0.2883 per tablet |
| liothyronine sodium 25 ug tablet | Brand: Cytomel | $0.5333 per tablet |
| liothyronine sodium 5 ug tablet | Generic | $0.2055 per tablet |
| liothyronine sodium 5 ug tablet | Brand: Cytomel | $0.3861 per tablet |
| liothyronine sodium 50 ug tablet | Generic | $0.3827 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sigmapharm Laboratories, LLC6 products
- Bryant Ranch Prepack6 products
- Teva Pharmaceuticals USA, Inc.3 products
- Pfizer Laboratories Div Pfizer Inc3 products
- Dr. Reddy's Labratories Inc.3 products
- A-S Medication Solutions3 products
- Biocon Pharma Inc.3 products
- Zydus Lifesciences Limited3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Zydus Pharmaceuticals USA Inc.3 products
- NorthStar Rx LLC3 products
- Asclemed USA, Inc.3 products
- Mylan Pharmaceuticals Inc.3 products
- Golden State Medical Supply, Inc.1 product
- Preferred Pharmaceuticals Inc.1 product
- XGen Pharmaceuticals DJB, Inc.1 product
- NuCare Pharmaceuticals, Inc.1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- Proficient Rx LP1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA010379 CYTOMEL | King Pharms | May 8, 1956 | 16, latest January 21, 2020 2020: Labeling · 2018: Labeling · 2002: Labeling |
Generic approvals (7)
- ANDA076923Xgen Pharms · August 17, 2005
- ANDA090097DR Reddys Labs SA · March 20, 2009
- ANDA200295Sigmapharm Labs LLC · November 29, 2012
- ANDA091382Sun Pharm · April 20, 2016
- ANDA211510Teva Pharms USA · October 26, 2018
- ANDA214803Zydus Lifesciences · January 22, 2021
- ANDA218070Biocon Pharma · February 6, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 4, 2023 · Class II · Terminated · D-0150-2024
Failed Impurities/Degradation Specifications
Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 1 — SUN PHARMACEUTICAL INDUSTRIES INC
-
October 20, 2023 · Class II · Terminated · D-0083-2024
Failed Impurities/Degradation Specifications.
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 — SUN PHARMACEUTICAL INDUSTRIES INC
-
October 20, 2023 · Class II · Terminated · D-0084-2024
Failed Impurities/Degradation Specifications.
Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-39 — SUN PHARMACEUTICAL INDUSTRIES INC
-
April 22, 2014 · Class II · Terminated · D-1344-2014
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa. — SigmaPharm Laboratories LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cytomel, Pfizer Laboratories Div Pfizer Inc, effective May 18, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →