FDA Drug recall D-0291-2021
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90
- FDA Drug
- Class III
- terminated
- Published 2021-03-10
On 2021-03-10 the FDA classified a Class III recall of Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90 by Dr Reddy S Laboratories, citing failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0291-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-02-19 |
| Published | 2021-03-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA
Reason
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy 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 | a) T900406, exp 3/2021 b) T000078 exp 12/2021 T000079 exp 12/2021 T000080 exp 12/2021 T000081 exp 12/2021 T00008…a) T900406, exp 3/2021 b) T000078 exp 12/2021 T000079 exp 12/2021 T000080 exp 12/2021 T000081 exp 12/2021 T000082 exp 12/2021 T000083 exp 12/2021 T000084 exp 12/2021 T000085 exp 12/2021 T000086 exp 12/2021 T000087 exp 12/2021 T000088 exp 1/2022 T000311 exp 1/2022 T000312 exp 1/2022 T000313 exp 1/2022 T000314 exp 1/2022 T000315 exp 1/2022 T000316 exp 1/2022 T000317 exp 1/2022 T000318 exp 1/2022 T000319 exp 1/2022 T000320 exp 1/2022 T000500 exp 2/2022 T000501 exp 2/2022 T000502 exp 2/2022 T000503 exp 2/2022 T000504 exp 2/2022 T000505 exp 2/2022 T000506 exp 2/2022 T000507 exp 2/2022 T000508 exp 2/2022 T000509 exp 3/2022 T000510 exp 3/2022 T000647 exp 3/2022 T000648 exp 3/2022 T000651exp 3/2022 T000652 exp 3/2022 T000653 exp 3/2022 T000654 exp 3/2022 T000875 exp 4/2022 T000876 exp 4/2022 T000877 exp 4/2022 T000878 exp 4/2022 T000879 exp 4/2022 T000880 exp 4/2022 T000881 exp 4/2022 T000882 exp 4/2022 T000883 exp 4/2022 T000884 exp 4/2022 T0 |
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-0291-2021%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.