The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0840-2023·Announced 2023-06-07

Rifampin Capsules Recalled Due to Incomplete Stability Studies

Akorn, Inc. is recalling all lots of Rifampin Capsules USP 150 mg distributed nationwide due to manufacturing deviations. The company ceased business before completing required stability studies to verify the drug remains safe and effective throughout its shelf life.

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: FDA Class II recall with CGMP deviations related to incomplete stability studies. No illnesses or injuries have been reported, but the incomplete stability data represents a risk-of-harm scenario where the drug's long-term safety and efficacy cannot be fully verified.

Plain-English summary

Akorn, Inc. is recalling all lots of Rifampin Capsules USP 150 mg, 30-count bottles (Rx only), distributed nationwide in the USA and Puerto Rico. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations.

The company went out of business and could no longer continue or complete stability studies required by FDA regulations. Stability studies are critical to verify that a drug remains safe and effective throughout its approved shelf life. Without these studies, the FDA cannot confirm the product maintains its intended strength, quality, and purity.

Patients currently taking this medication should not stop their treatment without consulting their healthcare provider, as interrupting antibiotic therapy could be harmful. Patients should contact their pharmacist or healthcare provider to discuss alternative treatments or proper disposal of any remaining supply. Healthcare providers should review patient records for dispensing of this product and arrange suitable alternatives where needed.

The recalled product

Product
Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug
Hazard

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 (1)

  • All Lots

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 86 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 86 products in this recall →

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