Simvastatin Tablets — Class III drug recall D-0409-2015
Terminated recall by Micro Labs Usa, Inc S, reported 2015-03-18, distributed nationwide. Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
| Recall number | D-0409-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro Labs Usa, Inc S, Princeton, NJ, United States |
| Recall initiated | 2014-12-04 |
| Classified | 2015-03-11 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2018-04-25 |
| Distributed | Nationwide (US) |
| Quantity | 13,464 bottles |
| Reason classes | specification failure |
| NDC | 42571-0080-90 |
| Lot numbers | STEG004, STEG006 |
| Expiration dates | 2015-02, 2015-03 |
Product
Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
Reason for recall
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
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-0409-2015. 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.