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.

Class I - Dangerous
💊 Drugs Recalled: September 21, 2022 Akorn Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Akorn, Inc.
Reason for Recall:
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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.

Product Codes/Lot 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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1548-2022

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