RIFAMPIN FOR INJECTION USP — Class III drug recall D-0231-2016
Terminated recall by Akorn, Inc., reported 2015-11-25, distributed nationwide. Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
| Recall number | D-0231-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-08-20 |
| Classified | 2015-11-13 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-01-26 |
| Distributed | Nationwide (US) |
| Quantity | 6,861 vials |
| Reason classes | specification failure |
| NDC | 17478-0151-42 |
| Lot numbers | 14RIF1 |
| Expiration dates | 2016-09-30 |
Product
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Reason for recall
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
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-0231-2016. 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.