Simvastatin Tablets — Class III drug recall D-0817-2016
Terminated recall by Biocon Inc, reported 2016-04-20, distributed in CA, OH, PA. Subpotent Drug
| Recall number | D-0817-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocon Inc, Iselin, NJ, United States |
| Recall initiated | 2016-03-24 |
| Classified | 2016-04-08 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2017-12-04 |
| Distributed | CA, OH, PA |
| Quantity | 5,505 bottles |
| Reason classes | potency |
| NDC | 24658-0300-10, 24658-0300-90 |
| Lot numbers | 14S0042F5B |
| Expiration dates | 2016-04 |
Product
Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134
Reason for recall
Subpotent Drug
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-0817-2016. 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.