Dr — Class II drug recall D-0085-2022
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2021-11-10, distributed nationwide. Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipi
| Recall number | D-0085-2022 |
|---|---|
| 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) |
| Quantity | 696 bottles |
| 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/40 mg, 500 count 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 NDC 43598-743-05
Reason for recall
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
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-0085-2022. 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.