Simvastatin USP 40 mg — Class II drug recall D-0561-2023
Terminated recall by PD-Rx Pharmaceuticals, Inc., reported 2023-05-10, distributed nationwide. CGMP deviations.
| Recall number | D-0561-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK, United States |
| Recall initiated | 2023-04-06 |
| Classified | 2023-05-01 |
| Reported by FDA | 2023-05-10 |
| Terminated | 2024-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 393 bottles |
| Reason classes | cgmp |
| NDC | 43063-0726-30, 43063-0726-90 |
| Expiration dates | 2023-05-31, 2023-07-31, 2023-08-31, 2023-10-31, 2024-03-31, 2024-04-30 |
Product
Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
Reason for recall
CGMP deviations.
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-0561-2023. 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.