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Class II · ModerateRecall completed

Rifampin

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # A200171, Exp 12/2023
Where it was soldDistributed Nationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited Aurangabad 431 210 India foreign manufacturer
Brand nameRIFAMPIN
Generic nameRIFAMPIN
Active ingredient(s)RIFAMPIN
Distributed by / forLupin Pharmaceuticals Baltimore, Maryland 21202
NDC68180-659-06
Show the full FDA record
Full product labelRifampin 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 firmLupin Pharmaceuticals Inc.
DistributionDistributed Nationwide in the USA
Quantity16,056 30 count bottles
Recall initiated2022-12-12
Report date2023-01-18
Recall completed2024-01-31
Recall numberD-0100-2023
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.