Roughly 160,630 bottles of levothyroxine sodium tablets are under recall, the FDA said.

Overview

The US Food and Drug Administration (FDA) has upgraded a recall affecting approximately 160,630 bottles of levothyroxine sodium tablets, a widely used medication for thyroid hormone replacement. This decisive action comes following concerns about some lots falling below potency specifications, which may impact the effectiveness of treatment for hypothyroidism and related disorders12.

What Triggered the Recall?

• Recall Initiation: The recall, initiated in June 2025, affects various strengths of levothyroxine sodium tablets, with expiration dates through March 20261.
• Reason: Quality checks revealed that certain batches did not meet potency requirements. Specifically, tests found that some tablets contained less than the labeled amount of active ingredient (subpotency)1.
• FDA Classification: This recall has been classified as Class II as of July 14, 2025, meaning there is only a moderate risk—a product defect that might cause temporary or medically reversible adverse health consequences, but the probability of serious adverse outcomes is low12.

Key Facts About the Recall

Issue	Details
Recall Type	Class II (moderate health risk)
Products Affected	Levothyroxine sodium tablets, several strengths
Lots Involved	More than 160,000 bottles, multiple lot numbers
Distributor	Accord Healthcare, Inc. (manufactured by Intas Pharma)
FDA Notification	July 2025
Consequence	Potential reduced effectiveness of thyroid treatment

Why Is This Important for Patients?

Levothyroxine is a lifesaving medication prescribed for:

• Hypothyroidism (underactive thyroid)
• Suppression of TSH in thyroid cancer or goiter

If the medication is under-strength, patients may experience symptoms of insufficient thyroid hormone, including:

• Fatigue
• Weight gain
• Depression
• Cognitive impairment
• Cardiovascular symptoms (especially in high-risk groups: elderly, heart patients)12

What Should You Do if You Take Levothyroxine?

• Do not stop your medication without consulting your healthcare provider.
• Check the label: If you have received notification from your pharmacy or doctor, follow their instructions regarding returning or replacing the medicine.
• Monitor symptoms: Contact your provider if you notice symptoms of low thyroid hormone.
• Pharmacists and Providers: The FDA urges prompt removal of all affected lots from inventory to prevent any compromised patient therapy1.

Final Guidance

• Patient Safety: No press release has been issued, but consignees have been formally notified and are working to remove subpotent products from circulation.
• Public Health Risk: The FDA assesses the risk from this recall as moderate but not serious, thanks to the temporary and reversible nature of any adverse effects if patients consult their providers promptly12.

If you believe you may be affected by this recall, reach out to your pharmacist or healthcare provider for individualised guidance. Do not discontinue or modify your dosage on your own.

“Subpotent levothyroxine may lead to inadequate thyroid hormone levels, causing symptoms like fatigue, weight gain, and cognitive impairment, particularly dangerous in elderly patients or those with cardiac conditions”312.

1. https://www.hmpgloballearningnetwork.com/site/pln/news/fda-issues-class-ii-recall-multiple-strengths-levothyroxine-tablets-due-subpotency
2. https://www.theepochtimes.com/us/fda-upgrades-recall-on-160000-bottles-of-popular-thyroid-medication-5891058
3. https://www.hmpgloballearningnetwork.com/site/pln/news/recall-issued-multiple-lots-levothyroxine-sodium-tablets-due-subpotency
4. https://medicare.chpw.org/member-center/member-resources/prescription-drug-coverage/drug-recall-report/
5. https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls
6. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ibsa-pharma-inc-issues-voluntary-nationwide-recall-select-lots-tirosintr-sol-levothyroxine-sodium
7. https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-teva-uk-limited-levothyroxine-12-dot-5mcg-tablets-el-23-a-slash-06
8. https://www.hcplive.com/view/voluntary-recall-announced-levothyroxine-sodium-oral-solution-hypothyroidism
9. https://ndclist.com/ndc/33342-402/recalls
10. https://www.ipdpharma.com/wp-content/uploads/2025/06/Accord-Levothyroxine-Recall-6.20.2025.pdf
11. https://www.news-medical.net/news/20180816/Two-thyroid-medications-recalled-by-FDA.aspx
12. https://www.pharmacy.ca.gov/about/recall_alerts/123124_lupin.pdf
13. https://www.accessdata.fda.gov/cms_ia/importalert_189.html
14. https://www.chpw.org/provider-center/pharmacy/drug-recall-report/
15. https://www.clsnetlink.com/LinkClick.aspx?fileticket=5xufQXHlo0k%3D&tabid=128&mid=692
16. https://www.pharmacy.ca.gov/about/recall_alerts/111924_mylan2.pdf
17. https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-18-2024-87175.pdf
18. https://www.pharmacy.ca.gov/about/recall_alerts/111924_mylan.pdf