Is levothyroxine being recalled in May 2025? Here's What You Need to Know

In May 2025, the U.S. Food and Drug Administration (FDA) issued a Class II recall for specific lots of levothyroxine sodium tablets from Accord Healthcare due to subpotency. This was one of several actions taken throughout 2025 concerning thyroid medication manufactured by Intas Pharmaceuticals for Accord Healthcare.

Quick Summary

Several recalls for subpotent levothyroxine sodium tablets were initiated in 2025, including some lots in May, June, and October. The recalls primarily involve products from Accord Healthcare, manufactured by Intas Pharmaceuticals, due to potency issues that could impact treatment efficacy.

Key Points

• May 2025 Recall: Specific lots of Accord Healthcare levothyroxine were recalled in May 2025 due to being subpotent, meaning they contained insufficient active ingredient.

• Multiple 2025 Recalls: The May recall was followed by additional levothyroxine recalls by Accord Healthcare throughout 2025 for similar subpotency issues.

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

• Check Your Medication: Patients should check their prescription bottles for the manufacturer (Accord Healthcare) and lot number to see if their medication is affected.

• Do Not Stop Abruptly: If your medication is recalled, consult your pharmacist and doctor to ensure a continuous and safe supply rather than stopping abruptly.

• Monitor for Symptoms: Patients who were on recalled medication should be monitored by their healthcare provider for potential returning symptoms of hypothyroidism.

The May 2025 Levothyroxine Recall

Yes, certain lots of levothyroxine distributed by Accord Healthcare were recalled in May 2025. On May 7, 2025, a Class II voluntary recall was initiated for specific lots of levothyroxine sodium tablets in multiple strengths due to subpotency. These tablets were found to contain less active ingredient than specified. This initial recall was among several related actions in 2025 concerning products from the same manufacturer and distributor.

What "Subpotent" Means for Patients

Levothyroxine is a synthetic hormone used to treat hypothyroidism. Subpotent medication has less active ingredient than labeled, potentially leading to inadequate thyroid hormone replacement therapy and the return or persistence of hypothyroid symptoms. Symptoms can include fatigue, weight gain, depression, muscle pain, dry skin, and cognitive issues. Inadequate thyroid levels can pose more serious health risks for vulnerable individuals.

Additional Recalls in 2025

The May recall was part of a series of recalls involving Accord Healthcare and manufacturer Intas Pharmaceuticals in 2025. Other recalls included:

• June 20, 2025: Accord Healthcare recalled over 160,000 bottles of various strengths due to subpotency.
• July 2025: The FDA upgraded the June recall to a Class II classification.
• October 8, 2025: The FDA upgraded another recall for Accord Healthcare levothyroxine to a Class II classification.

These repeated issues suggest quality control concerns for specific products during this period. The FDA classifies recalls into different classes based on potential health risks. To understand what a Class II recall means, please refer to {Link: Local 12 local12.com}.

How to Check Your Levothyroxine Medication

To check if your levothyroxine is affected by a recall:

1. Identify the distributor and manufacturer: Check your bottle for Accord Healthcare (distributor) and Intas Pharmaceuticals (manufacturer).
2. Find the lot number and expiration date: This information is on the label or bottle.
3. Consult recall lists: Official recall details are available on the FDA website and from your pharmacy.
4. Contact your pharmacy: For assistance or if you have any questions.

Comparison of Recent Levothyroxine Recalls in 2025

Recall Date	Company	Reason for Recall	FDA Classification	Affect on Patient	Status
May 7, 2025	Accord Healthcare	Subpotent drug	Class II	Inadequate hormone replacement, possible return of symptoms	Completed (recalled lots removed)
June 20, 2025	Accord Healthcare	Subpotent drug (multiple strengths and lots)	Class II	Inadequate hormone replacement, possible return of symptoms	Completed (recalled lots removed)
October 8, 2025	Accord Healthcare	Subpotent drug (specific 88 mcg lot)	Class II	Inadequate hormone replacement, possible return of symptoms	Completed (recalled lots removed)
December 20, 2024	Lupin Pharmaceuticals	Failed impurity and degradation specs	Class II	Potential reduced efficacy and safety	Completed (terminated)

What Should You Do If Your Medication is Recalled?

If your medication is recalled, do not stop taking it without consulting a healthcare professional. Instead:

• Return medication: Contact your pharmacist to return the recalled medication and get a non-recalled supply.
• Consult your doctor: Discuss the recall with your doctor to monitor your thyroid levels and treatment.
• Report symptoms: Inform your doctor if you experience recurring hypothyroid symptoms.

Conclusion

Specific lots of levothyroxine distributed by Accord Healthcare were recalled in May 2025 due to subpotency. This was one of several similar Class II recalls by the same company in 2025. Patients should check their medication details against official recall notices and consult with their pharmacist and physician to ensure continuous and effective thyroid hormone replacement therapy. For further details on the Class II recall classification, see {Link: Local 12 local12.com}.

For more information on levothyroxine safety and management, refer to resources from the American Thyroid Association.

Frequently Asked Questions

Was there a levothyroxine recall in May 2025?

Yes, on May 7, 2025, Accord Healthcare voluntarily recalled several lots of levothyroxine sodium tablets due to subpotency.

Which company issued the levothyroxine recall in May 2025?

Accord Healthcare, Inc. issued the recall for levothyroxine tablets that were manufactured by Intas Pharmaceuticals.

What was the reason for the levothyroxine recall?

The recall was initiated because the medication was found to be subpotent, meaning it contained less active ingredient than specified, which could affect treatment efficacy.

What is a Class II recall, and how does it relate to levothyroxine?

The FDA defines a Class II recall as one where exposure to the product may cause temporary or medically reversible health consequences with a low probability of serious harm. This classification applied to the 2025 levothyroxine recalls. More details on Class II recalls can be found on {Link: Local 12 local12.com}.

What should I do if I have recalled levothyroxine medication?

Contact your pharmacist to return the recalled product and receive a non-recalled batch. You should also consult your doctor to monitor your thyroid levels and address any recurring symptoms.

How can I check if my levothyroxine is affected by the recall?

Check the label on your prescription bottle for the distributor (Accord Healthcare), the lot number, and the expiration date. You can compare this information against official FDA recall notices.

Were there other levothyroxine recalls in 2025?

Yes, Accord Healthcare initiated further recalls in June and October 2025. Additionally, Lupin Pharmaceuticals issued a separate recall for levothyroxine in late 2024 and early 2025.