Ezetimibe and Simvastatin Tablets 10mg/80 mg — Class II drug recall D-0389-2019
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2019-01-30, distributed nationwide. Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
| Recall number | D-0389-2019 |
|---|---|
| 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 | 2019-01-15 |
| Classified | 2019-01-22 |
| Reported by FDA | 2019-01-30 |
| Terminated | 2020-03-03 |
| Distributed | Nationwide (US) |
| Quantity | 118 bottles |
| NDC | 43598-0586-10 |
| Lot numbers | 43E021, 43E023 |
| Expiration dates | 2020-01 |
Product
Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10
Reason for recall
Presence of Foreign Substance: Product complaint of black speckles observed on 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-0389-2019. 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.