Recent FDA Alerts on Thyroid Medication Recalls
Staying informed about medication recalls is crucial for patient safety, especially for those with chronic conditions like hypothyroidism. The U.S. Food and Drug Administration (FDA) regularly issues alerts for drugs that do not meet quality standards. In 2025, a significant alert for Accord Healthcare’s Levothyroxine Sodium tablets was upgraded to a Class II recall, highlighting the importance of regular checks on your prescription medication.
Accord Healthcare Levothyroxine Sodium Recall (2025)
In the summer of 2025, Accord Healthcare, Inc. issued a voluntary recall for multiple strengths and lots of its Levothyroxine Sodium tablets. The manufacturer, Intas Pharmaceuticals, was found to have produced certain batches with subpotency, meaning the medication contained less active ingredient than specified. The initial recall was issued on June 20, 2025, and subsequently upgraded by the FDA to a Class II recall on July 14, 2025.
The risks associated with subpotent thyroid medication can be significant for patients who depend on consistent hormone levels to manage their condition. Potential health consequences include a return of hypothyroidism symptoms, and more severe outcomes for vulnerable populations like the elderly, pregnant women, and patients with cardiac issues.
Affected Lot Numbers for Accord Healthcare Recall (2025)
- Lot D2300042; Expiration December 31, 2025
- Lot D2300076; Expiration December 31, 2025
- Lot D2300087; Expiration December 31, 2025
- Lot D2300092; Expiration December 31, 2025
- Lot D2300104; Expiration December 31, 2025
- Lot D2300325; Expiration January 31, 2026
- Lot D2400536; Expiration February 28, 2026
- Lot D2400679; Expiration February 28, 2026
- Lot D2400722; Expiration March 31, 2026
Other Notable Thyroid Medication Recalls
Recalls are not a new phenomenon for thyroid medication. Several incidents over the last few years serve as important reminders for patients. These often stem from potency issues, where the medication is either too weak or too strong, or from manufacturing quality issues.
- Mylan Pharmaceuticals Levothyroxine Sodium (2023-2024): Mylan Pharmaceuticals voluntarily recalled specific lots of Levothyroxine Sodium tablets due to atypical or out-of-specification assay results. The company stated the potential risk to patients was negligible, but recalled the products out of an abundance of caution.
- IBSA Pharma TIROSINT-SOL (2023): In early 2023, IBSA Pharma Inc. recalled several lots of its TIROSINT®-SOL (levothyroxine sodium) Oral Solution because routine testing indicated the product was subpotent. The FDA classified this as a Class I recall, the most serious type.
- Acella Pharmaceuticals NP Thyroid (2020-2021): Acella Pharmaceuticals conducted several voluntary recalls for NP Thyroid (Thyroid Tablets, USP) due to both subpotency and superpotency issues in various lots. The FDA classified the 2021 recall as Class I, denoting a high risk of serious harm to patients.
What to do if your medication is recalled
- Do not stop taking your medication immediately. Abruptly stopping thyroid medication can cause a return of hypothyroidism symptoms and potentially trigger a medical emergency. The best course of action is to contact your healthcare provider or pharmacist for guidance.
- Check your bottle. Locate the lot number and expiration date on your prescription bottle. The lot number, in particular, is the key identifier for recalled products. You can compare this against the FDA enforcement report or pharmacy alerts.
- Contact your pharmacy. If you have an affected lot, your pharmacy can arrange for a replacement prescription with a new, non-recalled batch. Pharmacies are notified directly by manufacturers and the FDA about recalls and should be able to assist.
- Monitor your symptoms. Pay close attention to your body for any changes in your hypothyroid symptoms. These can include fatigue, weight gain, depression, and cognitive impairment. Report any concerning changes to your doctor.
- Report adverse events to the FDA. You can report any quality problems or side effects to the FDA's MedWatch Adverse Event Reporting program online or by phone.
Comparison of Recent Thyroid Medication Recalls
| Recall Incident | Recalled Product | Recalling Company | Recall Reason | FDA Class (Risk) |
|---|---|---|---|---|
| July 2025 | Levothyroxine Sodium Tablets | Accord Healthcare | Subpotency (below approved specifications) | Class II (Moderate Risk) |
| 2023-2024 | Levothyroxine Sodium Tablets | Mylan Pharmaceuticals | Atypical or out-of-specification assay results | Negligible Risk |
| Early 2023 | TIROSINT®-SOL Oral Solution | IBSA Pharma Inc. | Subpotency | Class I (Serious Risk) |
| 2020-2021 | NP Thyroid Tablets | Acella Pharmaceuticals | Subpotency and Superpotency | Class I (Serious Risk) |
Conclusion
Recalls of thyroid medications, though sometimes occurring with low risk, underscore the critical need for patients to be vigilant. The 2025 recall of Accord Healthcare's Levothyroxine Sodium tablets is a recent and prominent example of a widespread subpotency issue that could affect many people. While it is crucial not to panic or stop medication abruptly, taking proactive steps is essential. Always check your lot numbers, communicate with your healthcare provider or pharmacist, and stay informed through reliable sources like the FDA's recall database. Your careful attention to these alerts ensures the continuity and safety of your treatment plan. The FDA's website, accessible at www.fda.gov/safety/recalls-market-withdrawals-safety-alerts, provides the most current information.
