Rifampin Capsules — Class II drug recall D-1548-2022
Ongoing recall by Akorn, Inc., reported 2022-10-05, distributed nationwide. Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-
| Recall number | D-1548-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Gurnee, IL, United States |
| Recall initiated | 2022-09-21 |
| Classified | 2022-09-28 |
| Reported by FDA | 2022-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 177,439 bottles |
| Reason classes | specification failure |
| NDC | 61748-0018-01, 61748-0018-30, 61748-0018-60 |
| Expiration dates | 2022-09-30, 2022-10-31, 2022-12-31, 2023-01-31, 2023-02-28, 2023-03-31, 2023-07-31, 2023-11-30, 2024-02-29 |
Product
Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.
Reason for recall
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
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-1548-2022. 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.