Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Aug 5, 2014 (12 years ago)

Rifampin for Injection USP

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point

Cause type: Impurity / degradation

An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.

What was recalled

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

Affected NDC 17478-0151-42

Compare with the code on your package — it is the most precise check available.

Drug: Rifampin

Recalling firm
Akorn, Inc.
NDC code
17478-151-42
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1571-2014 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Rifampin recalls

See all

Other recalls by Akorn, Inc.

All 2014 recalls