FDA Issues Class II Recall for Subpotent Levothyroxine Tablets on July 28

Major Pharmaceuticals recalled levothyroxine sodium tablets nationwide after the FDA determined the medication was subpotent, meaning it delivers less active ingredient than labeled. The company initiated the recall on July 13, and the FDA upgraded it to Class II status on July 17. The affected tablets, sold under the Major and Cardinal brand names, were distributed nationwide starting January 2025 in multiple dosages ranging from 25 to 150 micrograms with expiration dates through January 2027.

What is subpotent medication and why does it matter

Subpotent drugs contain less active ingredient than they should, making them less effective at treating the condition. Levothyroxine sodium tablets treat hypothyroidism, enlarged thyroid glands, and certain thyroid cancers. Patients taking subpotent doses may not receive adequate treatment for their thyroid condition, potentially allowing symptoms to worsen or the underlying condition to progress.

Which levothyroxine lots are affected

Twelve different dosages and cartons are included in the recall, with lot numbers and expiration dates ranging from July 2026 to January 2027. Affected strengths include 25, 50, 75, 88, 112, and 150 microgram tablets packaged in 10-count blister packs sold individually or in cartons of 10 packs. According to Major Rugby’s recall letter, the tablets were distributed nationwide beginning in January 2025.

What patients should do now

Consumers should return recalled medication to the pharmacy where it was purchased. Major Pharmaceuticals stated that taking the recalled tablets “is not likely to cause adverse health effects,” but patients should consult their doctor or physician if they find the recalled product. The FDA classified this as a Class II recall on July 17, meaning the tablets may cause temporary adverse health consequences, though the manufacturer’s assessment suggests risk is low.

Class II recall designation explained

The FDA uses Class II recalls for products that may cause temporary adverse health effects but are unlikely to cause serious harm. This designation is more serious than Class III but less urgent than Class I. The recall was initiated July 13 and formally classified as Class II on July 17, giving patients and healthcare providers two weeks’ notice before the public announcement on July 27.

Final Thoughts

Patients taking levothyroxine should check their medication against the recall list and consult their doctor if affected. While the manufacturer states the subpotent tablets are unlikely to cause serious harm, returning them to the pharmacy and obtaining replacement medication ensures proper thyroid treatment.

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