Quick answers
- What is Levothyroxine used for?
- The FDA-approved label (Unithroid, Amneal Pharmaceuticals LLC, June 19, 2019) says: “Hypothyroidism UNITHROID is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Levothyroxine have a boxed warning?
- Yes. The FDA label for Unithroid has a boxed warning (“WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Levothyroxine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Levothyroxine been recalled?
- FDA enforcement reports list 98 recalls of products of this medicine; the newest started August 6, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Levothyroxine?
- 47 companies list prescription products of Levothyroxine in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Northwind Health Company, LLC.
What Levothyroxine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Hypothyroidism UNITHROID is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. …
— FDA label: Unithroid, Amneal Pharmaceuticals LLC, effective June 19, 2019. Read the full label on DailyMed →
The FDA has 274 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. Its heading: WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
. Read it on the full label →
272 of 274 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Capsule · Injection, powder, lyophilized, for solution · Solution · Injection, solution · Injection |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 579 in the FDA NDC Directory |
| Brand names | Tirosint, Tirosint Sol, Synthroid, Unithroid, Levoxyl, Thyquidity |
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 |
|---|---|---|
| levothyroxine sodium 0.025 mg tablet | Generic | $0.0352 per tablet |
| levothyroxine sodium 0.05 mg tablet | Generic | $0.0401 per tablet |
| levothyroxine sodium 0.075 mg tablet | Generic | $0.0468 per tablet |
| levothyroxine sodium 0.088 mg tablet | Generic | $0.0476 per tablet |
| levothyroxine sodium 0.1 mg tablet | Generic | $0.0495 per tablet |
| levothyroxine sodium 0.112 mg tablet | Generic | $0.0579 per tablet |
| levothyroxine sodium 0.125 mg tablet | Generic | $0.0575 per tablet |
| levothyroxine sodium 0.137 mg tablet | Generic | $0.0633 per tablet |
| levothyroxine sodium 0.15 mg tablet | Generic | $0.0566 per tablet |
| levothyroxine sodium 0.175 mg tablet | Generic | $0.0748 per tablet |
| levothyroxine sodium 0.2 mg tablet | Generic | $0.0849 per tablet |
| levothyroxine sodium 0.3 mg tablet | Generic | $0.1095 per tablet |
| levothyroxine sodium 100 ug tablet | Generic | $0.0495 per tablet |
| levothyroxine sodium 100 ug tablet | Brand: Levoxyl | $0.9708 per tablet |
| levothyroxine sodium 100 ug tablet | Brand: Synthroid | $1.66 per tablet |
| levothyroxine sodium 100 ug tablet | Brand: Unithroid | $4.21 per tablet |
| levothyroxine sodium 100 ug/5 mL solution | Brand: Thyquidity | $1.38 per mL |
| levothyroxine sodium 112 ug tablet | Generic | $0.0579 per tablet |
| levothyroxine sodium 112 ug tablet | Brand: Levoxyl | $1.12 per tablet |
| levothyroxine sodium 112 ug tablet | Brand: Synthroid | $1.66 per tablet |
| levothyroxine sodium 112 ug tablet | Brand: Unithroid | $4.21 per tablet |
| levothyroxine sodium 125 ug tablet | Generic | $0.0575 per tablet |
| levothyroxine sodium 125 ug tablet | Brand: Levoxyl | $1.13 per tablet |
| levothyroxine sodium 125 ug tablet | Brand: Synthroid | $1.66 per tablet |
| levothyroxine sodium 125 ug tablet | Brand: Unithroid | $4.23 per tablet |
| levothyroxine sodium 137 ug tablet | Generic | $0.0633 per tablet |
| levothyroxine sodium 137 ug tablet | Brand: Levoxyl | $1.15 per tablet |
| levothyroxine sodium 137 ug tablet | Brand: Synthroid | $1.66 per tablet |
| levothyroxine sodium 137 ug tablet | Brand: Unithroid | $4.23 per tablet |
| levothyroxine sodium 150 ug tablet | Generic | $0.0566 per tablet |
| levothyroxine sodium 150 ug tablet | Brand: Levoxyl | $1.17 per tablet |
| levothyroxine sodium 150 ug tablet | Brand: Synthroid | $1.66 per tablet |
| levothyroxine sodium 150 ug tablet | Brand: Unithroid | $4.23 per tablet |
| levothyroxine sodium 175 ug tablet | Generic | $0.0748 per tablet |
| levothyroxine sodium 175 ug tablet | Brand: Levoxyl | $1.39 per tablet |
| levothyroxine sodium 175 ug tablet | Brand: Synthroid | $1.66 per tablet |
| levothyroxine sodium 175 ug tablet | Brand: Unithroid | $4.23 per tablet |
| levothyroxine sodium 200 ug tablet | Generic | $0.0849 per tablet |
| levothyroxine sodium 200 ug tablet | Brand: Levoxyl | $1.34 per tablet |
| levothyroxine sodium 200 ug tablet | Brand: Synthroid | $1.66 per tablet |
| levothyroxine sodium 200 ug tablet | Brand: Unithroid | $4.25 per tablet |
| levothyroxine sodium 25 ug tablet | Generic | $0.0352 per tablet |
| levothyroxine sodium 25 ug tablet | Brand: Levoxyl | $0.7529 per tablet |
| levothyroxine sodium 25 ug tablet | Brand: Synthroid | $1.66 per tablet |
| levothyroxine sodium 25 ug tablet | Brand: Unithroid | $4.18 per tablet |
| levothyroxine sodium 300 ug tablet | Generic | $0.1095 per tablet |
| levothyroxine sodium 300 ug tablet | Brand: Synthroid | $1.66 per tablet |
| levothyroxine sodium 50 ug tablet | Generic | $0.0401 per tablet |
| levothyroxine sodium 50 ug tablet | Brand: Levoxyl | $0.8540 per tablet |
| levothyroxine sodium 50 ug tablet | Brand: Synthroid | $1.66 per tablet |
| levothyroxine sodium 50 ug tablet | Brand: Unithroid | $4.18 per tablet |
| levothyroxine sodium 75 ug tablet | Generic | $0.0468 per tablet |
| levothyroxine sodium 75 ug tablet | Brand: Levoxyl | $0.9449 per tablet |
| levothyroxine sodium 75 ug tablet | Brand: Synthroid | $1.66 per tablet |
| levothyroxine sodium 75 ug tablet | Brand: Unithroid | $4.20 per tablet |
| levothyroxine sodium 88 ug tablet | Generic | $0.0476 per tablet |
| levothyroxine sodium 88 ug tablet | Brand: Levoxyl | $0.9597 per tablet |
| levothyroxine sodium 88 ug tablet | Brand: Synthroid | $1.66 per tablet |
| levothyroxine sodium 88 ug tablet | Brand: Unithroid | $4.19 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.
- A-S Medication Solutions74 products
- Bryant Ranch Prepack62 products
- Northwind Health Company, LLC36 products
- IBSA Pharma Inc.30 products
- Proficient Rx LP28 products
- Preferred Pharmaceuticals Inc.28 products
- NuCare Pharmaceuticals, Inc.16 products
- Alvogen Inc.14 products
- Direct_Rx13 products
- Cardinal Health 107, LLC13 products
- Coupler LLC13 products
- Remedyrepack Inc.13 products
- XLCare Pharmaceuticals, Inc.12 products
- Asclemed USA, Inc.12 products
- AbbVie Inc.12 products
- Accord Healthcare Inc.12 products
- Camber Pharmaceuticals, Inc.12 products
- Macleods Pharmaceuticals Limited12 products
- Lupin Pharmaceuticals, Inc.12 products
- Lannett Company, Inc.12 products
- YARAL Pharma Inc.12 products
- Amneal Pharmaceuticals LLC12 products
- Amneal Pharmaceuticals NY LLC12 products
- NorthStar RxLLC11 products
- Pfizer Laboratories Div Pfizer Inc11 products
- Fresenius Kabi USA, LLC11 products
- American Health Packaging11 products
- NCS HealthCare of KY, LLC dba Vangard Labs10 products
- Mylan Institutional Inc.10 products
- Major Pharmaceuticals9 products
- Teva Pharmaceuticals, Inc.6 products
- Aurobindo Pharma Limited5 products
- Sagent Pharmaceuticals3 products
- Onesource Specialty Pharma Limited3 products
- MAIA Pharmaceuticals, Inc.3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Endo USA, Inc.3 products
- Redpharm Drug2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- Piramal Critical Care Inc2 products
- RedPharm Drug, Inc.1 product
- NuCarePharmaceuticals, Inc.1 product
- Oliva Therapeutics, LLC1 product
- Hikma Pharmaceuticals USA Inc.1 product
- NuCar Pharmaceuticals, Inc.1 product
- Zydus Lifesciences Limited1 product
- Fosun Pharma USA Inc.1 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 |
|---|---|---|---|
| NDA021116 THYRO-TABS | Alvogen | October 24, 2002 | 10, latest November 16, 2023 2023: Labeling · 2022: Efficacy · 2021: Efficacy |
| NDA021210 UNITHROID | Stevens J | August 21, 2000 | 7, latest December 10, 2018 2018: Labeling · 2014: Manufacturing (CMC) · 2009: Manufacturing (CMC) |
| NDA021301 LEVOXYL | King Pharms | May 25, 2001 | 12, latest December 20, 2018 2018: Labeling · 2014: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA021342 LEVO-T | Cediprof Inc | March 1, 2002 | 13, latest May 4, 2026 2026: Labeling · 2017: Labeling · 2017: Manufacturing (CMC) |
| NDA021402 SYNTHROID | Abbvie | July 24, 2002 | 13, latest February 20, 2024 2024: Labeling · 2022: Labeling · 2020: Labeling |
| NDA021924 TIROSINT | Ibsa | October 13, 2006 | 7, latest June 22, 2022 2022: Manufacturing (CMC) · 2017: Labeling · 2017: Labeling |
| NDA202231 LEVOTHYROXINE SODIUM | Fresenius Kabi USA | June 24, 2011 | 6, latest October 21, 2026 2026: Labeling · 2026: Labeling · 2014: Manufacturing (CMC) |
| NDA206977 TIROSINT-SOL | Ibsa | December 15, 2016 | 4, latest November 16, 2023 2023: Labeling · 2023: Labeling · 2021: Manufacturing (CMC) |
| NDA210632 LEVOTHYROXINE SODIUM | Fresenius Kabi USA | April 11, 2019 | — |
| NDA214047 THYQUIDITY | Stevens J | November 30, 2020 | — |
| NDA214253 LEVOTHYROXINE SODIUM | Hikma | May 17, 2021 | — |
Generic approvals (11)
- ANDA076187Mylan · June 5, 2002
- ANDA206163Piramal Critical · June 29, 2016
- ANDA208749Maia Pharms Inc · December 21, 2018
- ANDA209713Lupin · January 18, 2019
- ANDA212399Accord Hlthcare · October 19, 2020
- ANDA207588Watson Labs Teva · May 10, 2022
- ANDA211417Macleods Pharms · December 21, 2022
- ANDA215259Ascent Pharms Inc · January 18, 2023
- ANDA217066Zydus Pharms · March 24, 2023
- ANDA216414Aurobindo Pharma · July 16, 2024
- ANDA216729Onesource Specialty · March 5, 2025
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.
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August 6, 2026 · Class II · Ongoing · D-0775-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu — ACCORD HEALTHCARE, INC.
-
August 6, 2026 · Class II · Ongoing · D-0776-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun — ACCORD HEALTHCARE, INC.
-
August 6, 2026 · Class II · Ongoing · D-0783-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu — ACCORD HEALTHCARE, INC.
-
August 6, 2026 · Class II · Ongoing · D-0782-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, M — ACCORD HEALTHCARE, INC.
-
August 6, 2026 · Class II · Ongoing · D-0781-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehrad — ACCORD HEALTHCARE, INC.
-
August 6, 2026 · Class II · Ongoing · D-0777-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu — ACCORD HEALTHCARE, INC.
-
August 6, 2026 · Class II · Ongoing · D-0784-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 276 — ACCORD HEALTHCARE, INC.
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August 6, 2026 · Class II · Ongoing · D-0785-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, — ACCORD HEALTHCARE, INC.
-
August 6, 2026 · Class II · Ongoing · D-0780-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehrad — ACCORD HEALTHCARE, INC.
-
August 6, 2026 · Class II · Ongoing · D-0779-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617 — ACCORD HEALTHCARE, INC.
-
August 6, 2026 · Class II · Ongoing · D-0786-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-2 — ACCORD HEALTHCARE, INC.
-
August 6, 2026 · Class II · Ongoing · D-0778-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu — ACCORD HEALTHCARE, INC.
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July 13, 2026 · Class II · Ongoing · D-0708-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He — Major Pharmaceuticals
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July 13, 2026 · Class II · Ongoing · D-0700-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61 — Major Pharmaceuticals
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July 13, 2026 · Class II · Ongoing · D-0702-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61 — Major Pharmaceuticals
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July 13, 2026 · Class II · Ongoing · D-0705-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61 — Major Pharmaceuticals
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July 13, 2026 · Class II · Ongoing · D-0703-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61 — Major Pharmaceuticals
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July 13, 2026 · Class II · Ongoing · D-0706-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61 — Major Pharmaceuticals
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July 13, 2026 · Class II · Ongoing · D-0701-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61 — Major Pharmaceuticals
-
July 13, 2026 · Class II · Ongoing · D-0709-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He — Major Pharmaceuticals
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July 13, 2026 · Class II · Ongoing · D-0707-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He — Major Pharmaceuticals
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July 13, 2026 · Class II · Ongoing · D-0711-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal — Major Pharmaceuticals
-
July 13, 2026 · Class II · Ongoing · D-0704-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61 — Major Pharmaceuticals
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July 13, 2026 · Class II · Ongoing · D-0710-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal — Major Pharmaceuticals
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June 8, 2026 · Class II · Ongoing · D-0656-2026
Subpotent Drug
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun- — ACCORD HEALTHCARE, INC.
Showing the newest 25 of 98.
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
| RxCUI (RxNorm) | 892246, 892251, 892255, 905451, 905453, 905455, 905457, 905458, 905460, 905462 … (+10) |
|---|---|
| SPL set ID of the quoted label | 07562e72-7eaa-4ce6-94f0-e08814787e50 |
| FDA labels (SPL) | 274 |
| FDA applications | NDA021116, NDA021210, NDA021301, NDA021342, NDA021402, NDA021924, NDA202231, NDA206977, NDA210632, NDA214047, NDA214253, 11 ANDA |
| Active ingredients (FDA) | LEVOTHYROXINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Unithroid, Amneal Pharmaceuticals LLC, effective June 19, 2019; 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 →