Simvastatin Tablets — Class III drug recall D-0246-2015
Terminated recall by Micro Labs Usa, Inc S, reported 2014-11-19, distributed in NY. Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Conte
| Recall number | D-0246-2015 |
|---|---|
| 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 | 2014-08-19 |
| Classified | 2014-11-12 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2016-04-19 |
| Distributed | NY |
| Quantity | 1,008 bottles |
| Reason classes | specification failure |
| NDC | 42571-0010-90 |
| Lot numbers | STBG005 |
| Expiration dates | 2015-02 |
Product
Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
Reason for recall
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life 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-0246-2015. 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.