FDA Drug recall D-0629-2021
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd
- FDA Drug
- Class III
- terminated
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class III recall of Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd by Dr Reddy S Laboratories, citing failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0629-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-06-04 |
| Published | 2021-06-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
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.
Reason
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Identifiers
| ndc | 55111-121-30 |
|---|---|
| ndc | 55111-121-60 |
| ndc | 55111-121-90 |
| ndc | 55111-121-05 |
| ndc | 55111-121-10 |
| ndc | 55111-122-30 |
| ndc | 55111-122-60 |
| ndc | 55111-122-90 |
| ndc | 55111-122-05 |
| ndc | 55111-122-10 |
| ndc | 55111-123-30 |
| ndc | 55111-123-60 |
| ndc | 55111-123-90 |
| ndc | 55111-123-05 |
| ndc | 55111-123-10 |
| code_info | Lot #: C905064, C905065, Exp. Date 07/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0629-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.