FDA Upgrades Recall on 160,000+ Bottles of Thyroid Medication

By Denise Mann HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on July 24, 2025.

via HealthDay

THURSDAY, July 24, 2025 — The U.S. Food and Drug Administration (FDA) has upgraded a recall of a commonly prescribed thyroid medication due to what it described as "subpotent" active ingredients.

The recall of more than 160,000 bottles of levothyroxine sodium, which went into effect June 20, was upgraded to a Class II recall on July 23. Class II recalls occur when use of the drug poses a moderate public health risk, according to the FDA.

The recall was initiated because the medication content of the recalled pills is “below the approved specification,” according to the New York-based television network NTD.

No other details were available about the recall, including whether anyone has become ill from the weak pills.

Levothyroxine sodium is used to treat a sluggish thyroid gland (hypothyroidism). Left untreated, hypothyroidism can lead to heart problems and high cholesterol, among other issues, according to the Mayo Clinic..

The recalled drugs are manufactured by India-based Intas Pharmaceuticals for North Carolina-based Accord Healthcare, NTD reported. They total 160,630 bottles and come in various doses, strengths, and packages, including:

  • Lot D2400536; expiration date, Feb. 28, 2026

  • Lot D2300325; expiration date, Jan. 31, 2026

  • Lot D2400679; expiration date, Feb. 28, 2026

  • Lot D2300087; expiration date, Dec. 31, 2025

  • Lot D2300092; expiration date, Dec. 31, 2025

  • Lot D2400722; expiration date, March 31, 2026

  • Lot D2300104; expiration date, Dec. 31, 2025

  • Lot D2300076; expiration date, Dec. 31, 2025

  • Lot D2300042; expiration date, Dec. 31, 2025

  • Sources

  • U.S. Food and Drug Administration, alert, July 23, 2025
  • NTD, July 23, 2025
  • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Read more

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    Popular Keywords