The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1548-2022·Announced 2022-10-05

Akorn Rifampin Capsules Recalled for Impurity Specification Failure

Akorn is recalling Rifampin Capsules USP 300 mg (30-, 60-, and 100-count bottles) distributed nationwide because finished product exceeds the interim limit for 1-Methyl-4-Nitrosopiperazine impurity. The recall affects approximately 177,439 bottles.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving failed impurity specifications without reported hospitalizations or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported merit a High severity score.

Plain-English summary

Akorn, Inc. is recalling Rifampin Capsules, USP, 300 mg, in 30-count, 60-count, and 100-count bottles, distributed nationwide and in Puerto Rico. Approximately 177,439 bottles are affected.

The finished product in certain lots exceeds the interim limit of 5 ppm for 1-Methyl-4-Nitrosopiperazine (MNP). The impurity specification failure was detected through quality control testing.

Patients with affected batches should consult their healthcare provider or pharmacist. A complete list of affected lot numbers and expiration dates is available from the FDA.

The recalled product

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.
Manufacturer
Akorn, Inc.
Category
Drug
Hazard
Affected units
177,439

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot#: a) 3192827
  • Exp 10/31/2022
  • 3196136
  • Exp 12/31/2022
  • 3202198
  • Exp 07/31/2023
  • 3203658
  • 3209114
  • Exp 11/30/2023
  • 3203851
  • Exp 02/29/2024
  • b) 3191254
  • Exp 09/30/2022
  • 3192820
  • 3192822
  • 3192824
  • 3192825
  • 3196141
  • Exp 01/31/2023
  • 3196143

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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