Medications & Supplements/Prescription Drugs

Akorn Rifampin Capsules Recalled for Excessive Impurity Levels

Agency Publication Date: September 28, 2022

Summary

Akorn, Inc. is recalling 195,584 bottles of Rifampin capsules (150 mg and 300 mg) because tests revealed levels of an impurity called 1-Methyl-4-Nitrosopoperazine (MNP) that exceed safety limits. Rifampin is a prescription antibiotic used to treat tuberculosis and other infections. MNP is a type of nitrosamine, which is a substance that may increase the risk of cancer if a person is exposed to high levels over a long period of time. This recall affects various bottle sizes and lots distributed throughout the United States and Puerto Rico.

Risk

The product contains levels of the MNP impurity above the interim safety limit of 5 ppm. While this does not pose an immediate health threat, MNP is classified as a potential human carcinogen, and long-term exposure to levels above safety limits could potentially increase the risk of developing cancer.

What You Should Do

This recall affects Rifampin Capsules (150 mg and 300 mg) sold in 30, 60, and 100-count bottles under the Akorn Operating Company label.
Check your medication bottle for NDC codes 61748-015-30, 61748-018-30, 61748-018-60, or 61748-018-01. See the Affected Products section below for the full list of affected lot numbers and expiration dates.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Rifampin Capsules, USP (150 mg)

Variants: 150 mg, 30-count bottle

Lot Numbers:

3192818 (Exp 10/31/2022)

3199700 (Exp 03/31/2023)

3203853 (Exp 02/29/2024)

NDC:

61748-015-30

Distributed by: Akorn Operating Company, LLC

Product: Rifampin Capsules, USP (300 mg)

Variants: 300 mg, 30-count bottle, 60-count bottle, 100-count bottle

Lot Numbers:

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)

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)

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)

NDC:

61748-018-30

61748-018-60

61748-018-01

Distributed by: Akorn Operating Company, LLC

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90880

Status: Active

Manufacturer: Akorn, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (18,145 bottles; 177,439 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects Rifampin Capsules (150 mg and 300 mg) sold in 30, 60, and 100-count bottles under the Akorn Operating Company label.

Check your medication bottle for NDC codes 61748-015-30, 61748-018-30, 61748-018-60, or 61748-018-01. See the Affected Products section below for the full list of affected lot numbers and expiration dates.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Rifampin Capsules, USP (150 mg)

Variants: 150 mg, 30-count bottle

Lot Numbers:

3192818 (Exp 10/31/2022)

3199700 (Exp 03/31/2023)

3203853 (Exp 02/29/2024)

NDC:

61748-015-30

Distributed by: Akorn Operating Company, LLC

Product: Rifampin Capsules, USP (300 mg)

Variants: 300 mg, 30-count bottle, 60-count bottle, 100-count bottle

Lot Numbers:

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)

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)

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)

NDC:

61748-018-30

61748-018-60

61748-018-01

Distributed by: Akorn Operating Company, LLC