The Discontinuation of Nature-Throid
In September 2020, RLC Labs, the manufacturer of Nature-Throid and WP Thyroid, initiated a voluntary nationwide recall of all lots of these medications. This recall was prompted by FDA testing that revealed some lots were 'subpotent,' containing lower than the labeled amounts of thyroid hormones T4 and T3. The inconsistency in dosage posed health risks for patients with hypothyroidism.
The recall led to a prolonged shortage. Although the company mentioned manufacturing facility upgrades to address quality concerns, RLC Labs officially discontinued the Nature-Throid brand in 2024. Patients who relied on Nature-Throid must now consult their healthcare provider to find a replacement.
The FDA's Regulatory Actions Against Desiccated Thyroid Extracts (DTEs)
The issues surrounding Nature-Throid reflect broader challenges for desiccated thyroid extracts (DTEs). These medications, derived from animal thyroid glands, have been available through a 'grandfathered' status without formal FDA approval.
The FDA announced a new enforcement policy in August 2025 targeting unapproved animal-derived thyroid medications. Citing safety and consistency concerns, the agency sent letters to DTE manufacturers, including those for Armour Thyroid and NP Thyroid, indicating planned compliance actions. Patients on these medications were advised to switch to approved alternatives within 12 months, though the exact deadline remains somewhat unclear.
Implications of the FDA Ruling
This ruling has several important consequences:
- Availability: The FDA policy makes it unlikely that Nature-Throid or other DTEs would remain on the market long-term, even if re-released.
- Compounding pharmacies: The August 2025 FDA notice prohibits compounding pharmacies from preparing unapproved DTEs, removing an option for customized preparations.
- Patient Advocacy: The FDA's stance has generated opposition from patient groups and some medical professionals who believe DTEs are essential for certain patients.
Alternatives to Nature-Throid
Patients affected by the discontinuation and regulatory changes have several alternatives, which should be discussed with a healthcare provider. Options include FDA-approved synthetic hormones and, for a limited time, potentially other DTE products.
Synthetic Thyroid Hormones
- Levothyroxine (Synthroid, Levoxyl, Tirosint): This is a synthetic T4, the standard treatment for hypothyroidism.
- Liothyronine (Cytomel): A synthetic T3, used alone or with levothyroxine.
- Liotrix (Thyrolar): A synthetic T4/T3 combination.
Other Desiccated Thyroid Extracts (DTEs)
- Armour Thyroid: A porcine-derived DTE, subject to the same regulatory actions as other unapproved DTEs.
- NP Thyroid: Another DTE brand also impacted by the recent FDA ruling.
Comparing Thyroid Medication Options
| Feature | Nature-Throid (Discontinued DTE) | Levothyroxine (Synthetic T4) | Liothyronine (Synthetic T3) | Armour Thyroid / NP Thyroid (Current DTEs) |
|---|---|---|---|---|
| Composition | Porcine-derived T4 and T3 (and trace hormones) | Synthetic T4 only | Synthetic T3 only | Porcine-derived T4 and T3 (and trace hormones) |
| FDA Status | Not FDA-approved; Recalled & Discontinued | FDA-approved | FDA-approved | Not FDA-approved; facing potential removal by mid-2026 |
| Hormone Consistency | Historically inconsistent potency; led to recall | Stable and consistent dose | Stable and consistent dose | Potential for batch-to-batch variation |
| Primary Indication | Replacement therapy for hypothyroidism | Standard treatment for hypothyroidism | Used alone or with T4 for non-converting patients | Alternative for patients not responding to synthetic options |
| Availability | Unavailable (Discontinued in 2024) | Widely available | Widely available | Uncertain; potential market removal mid-2026 |
Making the Transition to a New Medication
Switching thyroid medications requires medical guidance. A successful transition depends on working closely with a healthcare provider.
Steps for a Successful Switch
- Consult with your doctor: Discuss all options. Your doctor will consider your health history and lab results.
- Monitor hormone levels: Blood tests will be used to establish a baseline and track your response to the new medication, allowing for dosage adjustments.
- Recognize symptoms: Be aware of potential symptoms of hypothyroidism or hyperthyroidism during the change. Report any changes to your doctor.
Conclusion
In summary, Nature-Throid is no longer available. Following a 2020 recall for potency issues, the manufacturer discontinued the product in 2024. This, combined with recent FDA actions against all unapproved DTEs, necessitates that patients find alternative treatments with their doctor's help. FDA-approved synthetic options like levothyroxine and liothyronine are available. Due to ongoing regulatory changes, close consultation with a healthcare provider is essential for a safe and effective transition.
