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FDA Elevates Levothyroxine Recall Due to Health Risks

10/11/2025

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Summary

Story summary

The FDA upgraded the recall to Class II on October 8 for 54,532 bottles of Levothyroxine Sodium Tablets, USP, 88 mcg, due to sub-potency and potential temporary health risks.
The recall was initially issued on September 16 for Levothyroxine Sodium Tablets, USP, 88 mcg that were manufactured for Accord Healthcare by Intas Pharmaceuticals in India.
A similar recall occurred on July 14 for over 160,000 bottles of the same medication.

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Story summary

The FDA upgraded the recall to Class II on October 8 for 54,532 bottles of Levothyroxine Sodium Tablets, USP, 88 mcg, due to sub-potency and potential temporary health risks.
The recall was initially issued on September 16 for Levothyroxine Sodium Tablets, USP, 88 mcg that were manufactured for Accord Healthcare by Intas Pharmaceuticals in India.
A similar recall occurred on July 14 for over 160,000 bottles of the same medication.