FDA Drug recall D-0085-2022
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, S…
- FDA Drug
- Class II
- terminated
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class II recall of Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, S… by Dr Reddy S Laboratories, citing failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastat….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0085-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-05 |
| Published | 2021-11-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
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
Identifiers
| ndc | 43598-742-30 |
|---|---|
| ndc | 43598-742-90 |
| ndc | 43598-742-10 |
| ndc | 43598-744-30 |
| ndc | 43598-744-90 |
| ndc | 43598-744-10 |
| ndc | 43598-743-30 |
| ndc | 43598-743-90 |
| ndc | 43598-743-05 |
| ndc | 43598-745-30 |
| ndc | 43598-745-90 |
| ndc | 43598-745-05 |
| code_info | L100208, exp 01/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0085-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.