Rifampin Injection (Akorn) – Impurity Specification Failure (2014)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
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 for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42
Brand
Akorn, Inc.
Lot Codes / Batch Numbers
Lot: 12RIF4A, Expiration Date: 9/30/2014
Products Sold
Lot: 12RIF4A, Expiration Date: 9/30/2014
Akorn, Inc. is recalling Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV due to Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point. 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 Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
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 10, 2026