FDA Upgrades Recall of 160,000+ Bottles of Levothyroxine Due to Subpotent Active Ingredients

Key Insights

• The FDA upgraded a recall of over 160,000 bottles of levothyroxine sodium tablets to Class II status on July 23, indicating moderate public health risk.
• The recall was initiated because the medication content falls below approved specifications, making the thyroid medication subpotent.
• Levothyroxine sodium is used to treat hypothyroidism and is one of the most widely prescribed medications in the United States.

The U.S. Food and Drug Administration has escalated a recall of levothyroxine sodium tablets to Class II status, affecting more than 160,000 bottles of the widely prescribed thyroid medication due to subpotent active ingredients.

The recall, which initially went into effect on June 20, was upgraded on July 23 to Class II classification, indicating that use of the drug poses a moderate public health risk. The FDA stated that the medication content of the recalled pills is "below the approved specification," prompting the regulatory action.

Affected Products and Manufacturers

The recalled drugs are manufactured by India-based Intas Pharmaceuticals for North Carolina-based Accord Healthcare. The recall encompasses 160,630 bottles across various doses, strengths, and packages, including potencies of 25 mcg, 50 mcg, 100 mcg, 112 mcg, 150 mcg, and 175 mcg.

Specific lot numbers affected by the recall include:

• 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)

Clinical Significance

Levothyroxine sodium is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough hormones. The drug acts as a replacement therapy to supplement natural thyroid levels and is one of the most widely prescribed medications in the United States.

Left untreated, hypothyroidism can lead to heart problems and high cholesterol, among other issues. The subpotent nature of the recalled medication could potentially compromise treatment effectiveness for patients relying on the therapy.

Regulatory Response

Class II recalls occur when use of a drug poses a moderate public health risk, according to the FDA. No additional details were available about the recall, including whether anyone has become ill from the weak pills or the specific extent of the potency deficiency.