FDA Drug recall D-0599-2021
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, N…
- FDA Drug
- Class III
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class III recall of Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, N… 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-0599-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-05-04 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
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.
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 # C905063, Exp 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-0599-2021%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.