FDA Drug recall D-1079-2018
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 5…
- FDA Drug
- Class III
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class III recall of Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 5… by Dr Reddy S Laboratories, citing failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvasta….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1079-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-08-02 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
Reason
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
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 | T60045 |
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-1079-2018%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.