Is there a recall on levothyroxine thyroid medications?

As of September 2025, there are active recalls for specific batches of levothyroxine sodium tablets, with actions taken by manufacturers like Accord Healthcare and Pfizer. These recalls primarily cite subpotency, meaning the medication's active ingredient is below the labeled specification.

Quick Summary

Yes, there are active recalls on certain lots of levothyroxine thyroid medication due to subpotency. This can lead to ineffective treatment, prompting a Class II recall. Patients should confirm if their specific lot is affected and contact a healthcare provider for guidance without discontinuing use.

Key Points

• Current Recalls: Yes, recalls have been issued by companies like Accord Healthcare and Pfizer in 2025 due to subpotency.

• Main Reason: The primary cause for recent levothyroxine recalls is subpotency, meaning the tablets contain less active ingredient than specified.

• Moderate Health Risk: The FDA has classified these recent recalls as Class II, indicating a moderate risk of temporary or reversible health issues.

• Patient Action: Do not stop your medication; consult your doctor or pharmacist immediately if your lot number is affected.

• Identify Products: Check the manufacturer's name, lot number, and expiration date on your prescription bottle against official FDA or manufacturer announcements.

• Vulnerable Populations: Subpotency poses a higher risk for infants, pregnant women, the elderly, and those with underlying cardiac issues.

Recent Recalls on Levothyroxine Thyroid Medications

Recent safety alerts from the U.S. Food and Drug Administration (FDA) confirm that several recalls have been issued for specific lots of levothyroxine sodium tablets in 2025 and late 2024. These recalls were initiated by the manufacturers themselves following quality control issues. The primary concern across multiple instances is subpotency, where the medication contains a lower amount of the active ingredient than stated on the label. Because levothyroxine has a narrow therapeutic index, even slight deviations in potency can lead to significant clinical consequences for patients.

Accord Healthcare Recall (2025)

In multiple actions throughout 2025, Accord Healthcare initiated and had the FDA classify Class II recalls for numerous lots of its levothyroxine sodium tablets.

• Initiation and Classification: The recall began in June 2025 and was upgraded by the FDA to Class II in July 2025. A Class II recall signifies a moderate health risk where use of the product may cause temporary or medically reversible adverse health consequences.
• Reason: The medication was found to be subpotent, with its active ingredient assay falling below approved specifications.
• Affected Products: The recall involved over 160,000 bottles across various strengths, with expiration dates extending through March 2026.
• Manufacturer: The recalled products were manufactured by Intas Pharmaceuticals Limited in India.

Pfizer's Levoxyl Recall (2025)

In August 2025, Pfizer voluntarily recalled certain lots of its brand-name Levoxyl (levothyroxine sodium) tablets.

• Initiation: The recall was initiated in late July 2025 and was classified as Class II by the FDA.
• Reason: The recall was also due to a subpotency issue, specifically concerning assay results from stability studies.
• Affected Products: This recall impacted certain lots of Levoxyl tablets in various strengths.

Mylan Pharmaceuticals Inc. Recall (2024)

In late 2024, Mylan Pharmaceuticals Inc. (a Viatris company) conducted a retailer-level recall of specific lots of its levothyroxine sodium tablets.

• Reason: The recall was made out of an abundance of caution due to atypical or out-of-specification assay results.
• Health Risk: Mylan stated that the potential risk to patients was negligible and no adverse reactions had been reported at the time.

Potential Health Risks of Subpotent Levothyroxine

When levothyroxine is subpotent, it fails to adequately replace thyroid hormone, causing the patient to experience or continue experiencing symptoms of hypothyroidism. The risks are particularly dangerous for certain patient populations:

• General Patients: Symptoms of fatigue, weight gain, increased sensitivity to cold, dry skin, and depression may re-emerge or worsen.
• Elderly and Cardiac Patients: Individuals with pre-existing heart conditions face a greater risk of experiencing cardiac pain, palpitations, or arrhythmias if their thyroid hormone levels are not properly managed.
• Pregnant Women and Infants: Inadequate thyroid hormone levels during pregnancy can lead to complications such as early miscarriage, fetal hyperthyroidism, and impaired fetal neural and skeletal development.

What to Do If Your Medication Is Recalled

For Patients

1. Do not stop taking your medication: Suddenly stopping your thyroid medication can be more dangerous than continuing with a potentially less potent dose. The FDA and manufacturers advise against discontinuing treatment without consulting a healthcare provider first.
2. Check your bottle: Locate the manufacturer name, lot number, and expiration date on your prescription bottle. These are the key identifiers for determining if your medication is part of the recall.
3. Contact your pharmacy or doctor: If your medication matches the recall information, contact your pharmacy to find out how to return the affected product and get a replacement. Consult your prescribing doctor to discuss alternative treatments or necessary monitoring.
4. Report adverse reactions: Any side effects or health problems believed to be related to a recalled drug should be reported to the FDA's MedWatch program.

For Healthcare Providers and Pharmacists

1. Check inventory: Review current stock and remove all affected lot numbers from the pharmacy inventory immediately.
2. Notify patients: Proactively contact patients who may have received the recalled medication to inform them of the situation and provide instructions.
3. Provide replacements: Offer unaffected replacement medication or an alternative brand as directed by the patient's physician.

Comparison of Recent Levothyroxine Recalls

Feature	Accord Healthcare (2025)	Pfizer (Levoxyl) (2025)	Mylan (2024)
Initiating Company	Accord Healthcare (manufactured by Intas)	Pfizer	Mylan Institutional Inc. (a Viatris company)
Recall Date(s)	May 2025; Upgraded July 2025	July 2025; Classified August 2025	December 2024
Reason	Subpotent Drug: Assay below approved specifications	Subpotent Drug: Assay results from stability testing	Atypical or out-of-specification assay results
FDA Classification	Class II (Moderate Risk)	Class II (Moderate Risk)	Class II (Moderate Risk)
Health Risk Assessment	Potential for temporary or reversible adverse health effects	Potential for temporary or reversible health effects	Negligible risk, caution only
Action for Patients	Consult healthcare provider for guidance	Consult healthcare provider for guidance	Contact provider for confirmation/replacement

How to Stay Informed About Drug Recalls

Since medication recalls can occur at any time, it is vital for patients and healthcare providers to know how to access the most current information. The FDA provides a centralized database for all recalls, market withdrawals, and safety alerts. For a broader range of product recalls across various government agencies, including the FDA, consumers can also use the Recalls.gov website. Staying proactive by periodically checking these resources or signing up for email alerts can help ensure you have the most up-to-date information regarding your prescriptions.

The Importance of Potency and Consistency

Levothyroxine is a narrow therapeutic index drug, meaning that a precise dosage is essential for effective treatment without causing adverse effects. The recent recalls highlight the critical importance of drug stability, as levothyroxine is sensitive to environmental factors like heat and moisture. Research has shown that product packaging can influence stability, with some studies indicating blister packaging may offer better protection than standard bottles. This sensitivity explains why manufacturers and the FDA maintain strict control over the medication's potency throughout its shelf life, and why issues like subpotency lead to recalls.

Conclusion

Yes, there are current recalls affecting levothyroxine thyroid medications from several manufacturers due to subpotency. The FDA has categorized these as Class II, signifying a moderate health risk, and has issued specific lot numbers for the recalled products. Patients currently taking levothyroxine should not panic or stop their medication suddenly. Instead, they should follow the recommended steps: check if their lot is affected, contact their pharmacist or doctor, and arrange for a replacement. As always, open communication with your healthcare provider is the best way to ensure the safety and efficacy of your treatment. The FDA's website and Recalls.gov are reliable resources for staying informed about any future medication recalls.

Frequently Asked Questions

Are there active recalls for levothyroxine medication?

Yes, as of September 2025, there are active recalls on specific lots of levothyroxine sodium tablets from manufacturers like Accord Healthcare and Pfizer due to subpotency concerns.

What is subpotency and why does it cause a recall?

Subpotency means the medication contains less of the active ingredient than the labeled amount. Because levothyroxine has a narrow therapeutic index, even a small reduction in potency can lead to ineffective treatment, causing symptoms of hypothyroidism to return or worsen.

What should I do if I think I have recalled levothyroxine?

First, check your prescription bottle for the manufacturer's name, lot number, and expiration date. If they match an official recall notice, contact your pharmacist or doctor for guidance. Do not stop taking your medication on your own.

Is it safe to stop taking my thyroid medication if it's recalled?

No, you should not stop taking your thyroid medication without consulting a healthcare provider. Suddenly discontinuing treatment can be dangerous and cause more harm than taking a subpotent dose temporarily.

How do I find my medication's lot number?

The lot number and expiration date are typically printed on the label of your prescription bottle, often near the manufacturer's information.

What are the signs of my thyroid medication being ineffective?

If your medication is subpotent, you may start experiencing symptoms of hypothyroidism again, such as fatigue, weight gain, increased sensitivity to cold, dry skin, and depression.

Where can I find an official list of current drug recalls?

You can find official lists of drug recalls on the FDA's Recalls, Market Withdrawals, & Safety Alerts page (fda.gov) and at Recalls.gov.

Why are levothyroxine medications recalled more often than other drugs?

Levothyroxine is a highly sensitive drug, susceptible to degradation when exposed to environmental factors like heat and moisture. This instability, combined with its narrow therapeutic index, makes maintaining precise potency challenging and can lead to more frequent recalls related to subpotency.

Can I switch to a different brand of levothyroxine?

Because levothyroxine has a narrow therapeutic index, switching brands should only be done under the supervision of your doctor. Any change requires careful monitoring to ensure proper thyroid hormone levels are maintained.