High FDA (Drugs)·D-0165-2023·Announced 2023-01-25

Prescription Rifampin Capsules Recalled Due to Failed Quality Specifications

Amerisource Health Services is recalling Rifampin Capsules USP 300 mg nationwide due to failed impurities and degradation specifications. Affected patients should contact their healthcare provider before using remaining inventory.

What this means for you

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 is an FDA Class II drug recall where the product failed impurities and degradation quality specifications. No illnesses or injuries have been reported, but the failed quality standards represent a risk-of-harm product where injury has not yet been reported, qualifying it as High severity per the rubric.

Plain-English summary

Amerisource Health Services LLC is recalling Rifampin Capsules USP 300 mg (100 capsules per carton) distributed nationwide. The affected product is identified by lot number 1007805 with an expiration date of December 31, 2023.

The recall was initiated because this lot failed to meet impurities and degradation specifications during quality control testing. This indicates the product does not meet pharmaceutical standards for chemical purity and stability.

A total of 3,091 cartons have been distributed nationwide. Patients with prescriptions for this lot should contact their healthcare provider or pharmacist before using any remaining inventory. Healthcare providers should advise patients not to use this lot without medical guidance.

The recalled product

Product: RIFAMPIN (RIFAMPIN)
Brand: RIFAMPIN
Manufacturer: Amerisource Health Services LLC
Category: Drug — Prescription Antibiotic
Hazard: impurity-failure
product-degradation
Affected units: 3,091

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 (2)

Lot #: 1007805
exp. 12/31/2023

Distribution

Distributed nationwide across the United States.

Same brand · RIFAMPIN

High
Rifampin Antibiotic Capsules Recalled for Subpotency and Failed Specifications
FDA (Drugs) · 2024-02-07
High
Antibiotic Rifampin Capsules Recalled for Subpotency and Quality Failures
FDA (Drugs) · 2024-02-07
High
Rifampin Capsules Recalled Due to Failed Impurity and Degradation Specification
FDA (Drugs) · 2024-02-07
High
Prescription Rifampin Capsules Recalled for Failed Impurity Specifications
FDA (Drugs) · 2023-01-18
Moderate
Rifampin Capsules Recalled Due to Manufacturing Control Deviation
FDA (Drugs) · 2022-08-24

Same manufacturer · Amerisource Health Services LLC

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