Atorvastatin Calcium tablets — Class III drug recall D-1079-2018
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2018-08-22, distributed nationwide. Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradatio
| Recall number | D-1079-2018 |
|---|---|
| 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 | 2018-08-02 |
| Classified | 2018-08-14 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2020-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 2,280 bottles |
| 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 |
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 for recall
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.
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-1079-2018. 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.