CLASS II ONGOING Drug recall · Reported 5 Oct 2022 · FDA Enforcement Report

Rifampin Capsules, USP, 300 mg, a) bottle recalled by Akorn

Akorn is recalling Rifampin Capsules, USP, 300 mg, a) bottle (, distributed nationwide in the US. The recall was initiated on 21 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot#: 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

Quantity recalled177,439 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1548-2022
FDA event ID: 90880
Recalling firm: Akorn, Gurnee, IL
Classification: Class II
Status: Ongoing
Recall initiated: 21 Sep 2022
FDA classified: 28 Sep 2022
Reported: 5 Oct 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity

Timeline

21 Sep 2022	Recall initiated by company
28 Sep 2022	Classified by FDA	+7 days
5 Oct 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

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.

Where it was distributed

USA Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Which lots are affected?

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

Where was it sold?

USA Nationwide and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 90880

This product is part of a recall event; the main page for the event is Rifampin Capsules, USP, 150 mg recalled by Akorn.

Reported	Class	Recall	Company	Reason	Where
5 Oct 2022	CLASS II	Rifampin Capsules, USP, 150 mg recalled by Akorn	Akorn	Nitrosamine Impurity	Nationwide

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Other Rifampin recalls

All 21

Reported	Class	Recall	Company	Reason	Where
17 Apr 2024Drug	CLASS II	Rifampin Capsules USP, 300mg recalled by Lupin Pharmaceuticals	Lupin Pharmaceuticals	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS II	Rifampin Capsules USP 300mg recalled by Lupin PharmaceuticalsRifampin	Lupin Pharmaceuticals	Potency & Assay	MD
7 Feb 2024Drug	CLASS II	Rifampin Capsules USP, 150 mg doses recalled	Amerisource Health Services	Potency & Assay	Nationwide
7 Feb 2024Drug	CLASS II	Rifampin Capsules USP 150mg recalled by Lupin PharmaceuticalsRifampin	Lupin Pharmaceuticals	Potency & Assay	MD
7 Jun 2023Drug	CLASS II	Rifampin Capsules USP, 150 mg recalled by Akorn	Akorn	Potency & Assay	Nationwide