US Drug Recall Register
Class III · Low risk Terminated Initiated May 4, 2021 (5 years ago)

Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities

What was recalled

Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.

Recalling firm
Dr. Reddy's Laboratories, Inc.
NDC code
55111-121-05
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0599-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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