Unlikely to cause harm — often a labeling or packaging issue.
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
| Brand name | ATORVASTATIN CALCIUM |
| Generic name | ATORVASTATIN CALCIUM |
| Active ingredient(s) | ATORVASTATIN CALCIUM TRIHYDRATE |
| Distributed by / for | Dr. Reddy's Laboratories, Inc. |
| NDC | 55111-121-05 |
| Full product label | Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05. |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Distribution | Nationwide within the United States |
| Quantity | 5984 bottles |
| Recall initiated | 2021-06-04 |
| Report date | 2021-06-23 |
| Recall completed | 2023-02-16 |
| Recall number | D-0629-2021 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗