Story perspectives

FDA Recalls 140,000 Atorvastatin Bottles Over Dissolution Issues

10/24/2025

Summary

Story summary

The FDA recalls more than 140,000 bottles of Atorvastatin Calcium tablets due to failed dissolution specifications.
Ascend Laboratories initiated the recall.
The tablets were manufactured by Alkem Laboratories in India.
The affected strengths are 10 mg, 20 mg, 40 mg, and 80 mg with expiration through February 2027.
The FDA classifies the recall as Class II and directs patients to check their bottles and consult providers for alternatives if affected.

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Story summary

The FDA recalls more than 140,000 bottles of Atorvastatin Calcium tablets due to failed dissolution specifications.
Ascend Laboratories initiated the recall.
The tablets were manufactured by Alkem Laboratories in India.
The affected strengths are 10 mg, 20 mg, 40 mg, and 80 mg with expiration through February 2027.
The FDA classifies the recall as Class II and directs patients to check their bottles and consult providers for alternatives if affected.