Yes, specific lots of levothyroxine were recalled in 2025
Throughout 2025, several pharmaceutical manufacturers initiated voluntary recalls of levothyroxine sodium tablets. These actions were taken after quality control testing revealed certain batches were 'subpotent,' meaning the pills contained less than the labeled amount of the active ingredient. The FDA classified most of these as Class II recalls, indicating a moderate risk of temporary or medically reversible adverse health effects. While the risk of serious harm is considered low, insufficient potency could lead to uncontrolled hypothyroidism and a return of symptoms.
The Accord Healthcare and Pfizer recalls
Two notable recalls in 2025 involved different pharmaceutical companies. Accord Healthcare (manufactured by Intas Pharmaceuticals) issued a recall in June 2025, which the FDA upgraded to a Class II recall in July. This action affected more than 160,000 bottles across multiple dosage strengths, from 25 mcg to 175 mcg. The recall was prompted by out-of-specification results during long-term stability testing.
Separately, in late July 2025, Pfizer also initiated a voluntary recall of its brand-name levothyroxine product, Levoxyl (levothyroxine sodium) tablets. This recall was also due to subpotency discovered during routine stability testing. The affected lots included a specific batch of 29,004 bottles of 112 mcg tablets.
Understanding the implications of subpotent levothyroxine
For patients with hypothyroidism, consistent and accurate dosing is crucial for managing their condition effectively. Subpotent levothyroxine may lead to a recurrence of hypothyroid symptoms because it does not provide the body with the necessary level of thyroid hormone replacement. This can cause a number of health issues, including:
- Fatigue and lethargy: A common symptom of under-treated hypothyroidism.
- Weight gain: Inadequate thyroid hormone levels can slow metabolism, leading to weight gain.
- Cardiovascular issues: Patients with heart conditions are particularly vulnerable to the effects of inconsistent thyroid hormone replacement.
- Cognitive impairment: Inconsistent dosing can cause brain fog and difficulty concentrating.
Given these risks, it is essential for patients to check their medication and follow their healthcare provider's instructions carefully. It's important to remember that stopping your medication without professional guidance is not advised and could lead to more severe health problems.
A comparative overview of the 2025 recalls
| Feature | Accord Healthcare Recall | Pfizer (Levoxyl) Recall |
|---|---|---|
| Initiation | June 2025 | July 2025 |
| FDA Classification | Class II (upgraded July 2025) | Class II (August 2025) |
| Affected Products | Levothyroxine sodium tablets (25 mcg to 175 mcg) | Levoxyl (levothyroxine sodium) tablets (112 mcg) |
| Reason for Recall | Subpotency (Assay below specification) | Subpotency (Assay below specification) |
| Manufacturer | Intas Pharmaceuticals Ltd (India) | N/A (distributed by Pfizer Inc.) |
| Risk Level | Moderate: Potential for temporary or reversible adverse health effects | Moderate: Potential for temporary or reversible adverse health effects |
What to do if your medication is affected
If your levothyroxine has been affected by a recall, the following steps are recommended:
- Check your bottle's lot number: Locate the lot number and expiration date on your prescription bottle. If it matches the recalled products, do not continue taking it.
- Contact your pharmacy: Reach out to your pharmacist immediately. They can confirm if your specific prescription is part of the recalled batch and can often provide an unaffected replacement.
- Consult your healthcare provider: Speak with your doctor or endocrinologist. They can provide guidance on managing your medication, including whether to temporarily switch to another brand or formulation while waiting for a new supply.
- Do not stop taking your medication suddenly: Discontinuing levothyroxine abruptly can be harmful. Always consult a professional before changing your treatment plan.
- Report adverse effects: The FDA encourages patients and healthcare providers to report any adverse events associated with recalled medication through its MedWatch program.
How to stay informed on future drug safety alerts
Staying proactive about medication safety is the best defense against potential recalls. The FDA provides several resources for consumers to monitor alerts:
- FDA website: Regularly check the FDA's enforcement report for the latest recall information.
- MedWatch alerts: Sign up for email alerts from the FDA's MedWatch program to receive information directly.
- Pharmacy notifications: Many pharmacies have systems in place to contact patients directly when a recall affects their medication. Ensure your contact information is up to date.
Conclusion
While it is unsettling to learn about a recall involving a necessary medication, it is important to remember that these actions are taken to ensure patient safety. Several specific lots of levothyroxine were recalled in 2025 by manufacturers like Accord Healthcare and Pfizer due to confirmed issues with subpotency. However, the vast majority of levothyroxine in circulation remains safe and effective. By verifying your medication's lot number with your pharmacy and consulting your doctor, you can navigate this situation calmly and ensure your treatment is not interrupted. These events underscore the vital importance of pharmaceutical quality control and the need for patients to be informed and proactive about their health.
