FDA Drug recall D-0418-2018
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDI…
- FDA Drug
- Class III
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class III recall of Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDI… by Dr Reddy S Laboratories, citing failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0418-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-01-29 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05
Reason
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
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 numbers: a) T600125, 3/2018; T600201, T600248 5/2018, b) T600125, 3/2018; T600201, and T600248, 5/2018 |
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-0418-2018%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.