Rifampin Capsules (Akorn) – Impurity Specification Failure (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Akorn, Inc.
Lot Codes / Batch Numbers
Lot#: a) 3192827, Exp 10/31/2022, 3196136, Exp 12/31/2022, 3202198, Exp 07/31/2023, 3203658, Exp 07/31/2023, 3209114, Exp 11/30/2023, 3203851, Exp 02/29/2024, b) 3191254, Exp 09/30/2022, 3192820, Exp 09/30/2022, 3192822, Exp 10/31/2022, 3192824, Exp 10/31/2022, 3192825, Exp 10/31/2022, 3196141, Exp 01/31/2023, 3196143, Exp 02/28/2023, 3203870, Exp 11/30/2023, 3203871, Exp 02/29/2024, c) 3190636, Exp 09/30/2022, 3192813, Exp 09/30/2022, 3196132, Exp 12/31/2022, 3196133, Exp 12/31/2022, 3196138, Exp 01/31/2023, 3199702, Exp 03/31/2023, 3199703, Exp 03/31/2023
Products Sold
Lot#: a) 3192827, Exp 10/31/2022; 3196136, Exp 12/31/2022; 3202198, Exp 07/31/2023; 3203658, Exp 07/31/2023; 3209114, Exp 11/30/2023; 3203851, Exp 02/29/2024; b) 3191254, Exp 09/30/2022; 3192820, Exp 09/30/2022; 3192822, Exp 10/31/2022; 3192824, Exp 10/31/2022; 3192825, Exp 10/31/2022; 3196141, Exp 01/31/2023; 3196143, Exp 02/28/2023; 3203870, Exp 11/30/2023; 3203871, Exp 02/29/2024; c) 3190636, Exp 09/30/2022; 3192813, Exp 09/30/2022; 3196132, Exp 12/31/2022; 3196133, Exp 12/31/2022; 3196138, Exp 01/31/2023; 3199702, Exp 03/31/2023; 3199703, Exp 03/31/2023
Akorn, Inc. is recalling Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748 due to Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026