Atorvastatin Calcium Tablets — Class III drug recall D-0291-2021
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2021-03-10, distributed nationwide. Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy
| Recall number | D-0291-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2021-02-19 |
| Classified | 2021-03-01 |
| Reported by FDA | 2021-03-10 |
| Terminated | 2023-09-07 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 55111-0121, 55111-0121-05, 55111-0121-10, 55111-0121-30, 55111-0121-60, 55111-0121-90, 55111-0122, 55111-0122-05, 55111-0122-10, 55111-0122-30, 55111-0122-60, 55111-0122-90, 55111-0123, 55111-0123-05, 55111-0123-10, 55111-0123-30, 55111-0123-60, 55111-0123-90 |
| Expiration dates | 2021-03, 2021-04, 2021-05, 2021-07, 2021-10, 2021-11, 2021-12, 2022-01, 2022-02, 2022-03, 2022-04, 2022-05 |
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 for recall
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0291-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.