FDA Recalls Levothyroxine Nationwide: What You Need to Know

Food and Drug Administration (FDA). The nationwide recall involves multiple dosage strengths of Levothyroxine Sodium Tablets packaged in 10-count blister packs.

Levothyroxine Sodium Tablets Recall Details and Classifications

According to the FDA, the recall was initiated on July 13 and designated as a Class II on July 17. A Class II designation indicates that the use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences. The medication is prescribed to treat hypothyroidism and goiter, according to the Mayo Clinic. Because the tablets are subpotent, patients taking them may not receive the intended therapeutic dose required to manage their thyroid conditions properly.

Distribution and Packaging Information

Major Pharmaceuticals packaged and distributed the recalled Levothyroxine Sodium Tablets nationwide, with Cardinal Health also handling some distribution, the FDA stated. The affected drugs were distributed in 10-count blister packs, which were sold either individually or packaged inside cartons containing 10 packs for a total of 100 tablets. The FDA did not disclose the total number of tablets included in the voluntary recall.

Affected Dosages and Expiration Dates

The recall affects tablets spanning six distinct microgram strengths. According to federal regulators, the impacted products include:

• 25 microgram tablets
• 50 microgram tablets
• 75 microgram tablets
• 88 microgram tablets
• 112 microgram tablets
• 150 microgram tablets

The expiration dates for the recalled batches range from July 2026 to January 2027, according to the FDA.

Frequently Asked Questions

Why were the Levothyroxine Sodium Tablets recalled?

The FDA announced that the tablets are subpotent, meaning they do not contain the full amount of active ingredient required to be fully effective.

Which companies distributed the recalled medication?

Major Pharmaceuticals packaged and distributed the medication nationwide, and Cardinal Health also distributed portions of it, according to federal regulators.

What are the expiration dates of the affected batches?

The recalled tablets carry expiration dates ranging from July 2026 to January 2027.

What health risks are associated with a Class II recall?

According to the FDA, a Class II designation means the product may cause temporary or medically reversible adverse health consequences.