US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 12, 2022 (4 years ago)

Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06

Recalling firm
Lupin Pharmaceuticals Inc.
NDC code
68180-659-06
Origin
MD, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0100-2023

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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