Agency classClass IIOur severity:High FDA (Drugs)·D-0774-2022·Announced 2022-04-27

Injectable Rifampin Recalled Due to Failed Quality Specifications

Mylan Pharmaceuticals is recalling injectable Rifampin vials nationwide due to failed impurities and degradation specifications discovered during stability 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 an injectable pharmaceutical with failed quality specifications—impurity and degradation product levels exceeding established standards. No illnesses or hospitalizations have been reported, making this a risk-of-harm product where injury has not yet been documented.

Plain-English summary

Mylan Pharmaceuticals Inc is recalling Rifampin for Injection, USP (600 mg/vial) nationwide. The recall affects 33,893 vials due to failed impurities and degradation specifications.

During stability testing, Mylan found that related compounds in the affected lots were present at levels exceeding the established specifications. This failure means the product may not meet required quality standards.

The recall includes four specific lot numbers with varying expiration dates between December 2022 and April 2023. Patients receiving Rifampin from these lots may be affected.

Healthcare providers and patients should verify the lot number on their medication. If you have received Rifampin from one of the affected lots, contact your healthcare provider or pharmacist for guidance. Do not use recalled product and return it to the pharmacy for proper disposal.

The recalled product

Product: RIFAMPIN (RIFAMPIN)
Brand: RIFAMPIN
Manufacturer: Mylan Pharmaceuticals Inc
Category: Drug — Injectable Antibiotic
Hazard: impurity
degradation-product
Affected units: 33,893

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 (7)

Lot #: 7008990
exp. date Dec-2022
7009025
exp. date Feb-2023
7009085
7009086
exp. date Apr-2023

Distribution

Distributed nationwide across the United States.

Same brand · RIFAMPIN

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FDA (Drugs) · 2023-01-18

Same manufacturer · Mylan Pharmaceuticals Inc

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Same hazard · impurity