FDAClass IIJanuary 18, 2023

Rifampin Capsules USP recall: Impurity Out of Spec

Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin…

Why was Rifampin Capsules USP recalled?

Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # A200171, Exp 12/2023

Product
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin…
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
16,056 30 count bottles
Distribution
Distributed Nationwide in the USA
Recall date
January 18, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls