US Drug Recall Register
Class III · Low risk Terminated Initiated Jun 12, 2018 (8 years ago)

Atorvastatin Calcium Tablets

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

Why it was recalled

Failed Impurities/Degradation Specifications

What was recalled

Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90

Recalling firm
Dr. Reddy's Laboratories, Inc.
NDC code
55111-121-90
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0886-2018

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.

Other Atorvastatin recalls

See all
Class II · Moderate risk Ongoing

Atorvastatin Calcium Tablets USP

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-514-90 D-0020-2026
Class II · Moderate risk Ongoing

Atorvastatin Calcium Tablets USP

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-512-90 D-0019-2026
Class II · Moderate risk Ongoing

Atorvastatin Calcium Tablets USP

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-513-90 D-0018-2026
Class II · Moderate risk Ongoing

Atorvastatin Calcium Tablets USP

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-511-90 D-0017-2026
Class II · Moderate risk Ongoing

Atorvastatin Calcium Tablets USP 40 mg

Reason Failed dissolution specifications: lower than specifications

Biocon Pharma INC NDC 70377-079-13 D-0306-2025