Dr — Class II drug recall D-0083-2022
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2021-11-10, distributed nationwide. Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
| Recall number | D-0083-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2021-10-05 |
| Classified | 2021-10-29 |
| Reported by FDA | 2021-11-10 |
| Terminated | 2023-02-16 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 43598-0742, 43598-0742-10, 43598-0742-30, 43598-0742-90, 43598-0743, 43598-0743-05, 43598-0743-30, 43598-0743-90, 43598-0744, 43598-0744-10, 43598-0744-30, 43598-0744-90, 43598-0745, 43598-0745-05, 43598-0745-30, 43598-0745-90 |
| Expiration dates | 2023-01 |
Product
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
Reason for recall
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
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-0083-2022. 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.