The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0841-2023·Announced 2023-06-07

Rifampin Capsules Recall: Incomplete Stability Studies Due to Manufacturer Closure

Akorn Inc. is recalling all lots of Rifampin Capsules USP 300 mg distributed nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required testing.

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 FDA Class II recall involves a prescription drug with unconfirmed stability due to incomplete testing. While no illnesses or injuries have been reported and the hazard is theoretical, this represents a risk-of-harm product where stability confirmation is critical. The theoretical nature of the hazard and absence of reported harm place this at the maximum allowable score for such recalls.

Plain-English summary

Akorn Inc. is recalling all lots of Rifampin Capsules USP 300 mg distributed nationwide in the USA and Puerto Rico, available in 30 and 60 count bottles. The FDA has classified this as a Class II recall due to Good Manufacturing Practice (GMP) deviations.

The firm ceased operations and could no longer conduct stability studies required to confirm the product maintains its safety and effectiveness throughout its shelf life. Stability testing is critical to ensure medications do not degrade and remain effective.

Patients taking Rifampin should contact their healthcare provider or pharmacist for guidance on whether to continue or discontinue use. Healthcare providers may consider whether alternative treatments are appropriate for affected patients.

The product was distributed nationwide in the USA and Puerto Rico and may remain in pharmacies and patients' homes. Consumers should not dispose of medication without consulting their pharmacist.

The recalled product

Product
Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, 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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