Rifampin Capsule
FDA Recall NDC 68180-658
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Rifampin (NDC 68180-658). A significant event, classified as Class II, was initiated on Jan 05, 2024 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Subpotent Drug and Failed Impurities/Degradation Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
January 2024 Class II Recall: Subpotent Drug and Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Subpotent Drug and Failed Impurities/Degradation Specifications
Jan 05, 2024
Feb 07, 2024
15,576 Bottles
Recall Profile & Regulatory Data
Event ID
93753
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
Termination Date
Aug 27, 2024
Product Description
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06
Batch or Lot Expiration Information
Lot# A200816 exp 1/2024 A201248 exp 3/2024
Affected Packages Involved in this Recall
68180-658-06Product
68180-658-01Product
68180-659-06Product
68180-659-07Product
68180-659-01Product
January 2024 Class II Recall: Subpotent Drug and Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Subpotent Drug and Failed Impurities/Degradation Specifications
Jan 05, 2024
Feb 07, 2024
165,60 bottles
Recall Profile & Regulatory Data
Event ID
93753
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
Termination Date
Aug 27, 2024
Product Description
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
Batch or Lot Expiration Information
Lot# A200817 exp 1/2024
Affected Packages Involved in this Recall
68180-658-06Product
68180-658-01Product
68180-659-06Product
68180-659-07Product
68180-659-01Product
December 2022 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Dec 12, 2022
Jan 18, 2023
16,056 30 count bottles
Recall Profile & Regulatory Data
Event ID
91295
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jan 31, 2024
Product Description
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
Batch or Lot Expiration Information
Lot# A200171, Exp 12/2023
Affected Packages Involved in this Recall
68180-658-06Product
68180-658-01Product
68180-659-06Product
68180-659-07Product
68180-659-01Product
Class II Terminated
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Jul 28, 2022
Aug 24, 2022
7,872/30 count bottles
Recall Profile & Regulatory Data
Event ID
90616
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide.
Termination Date
Oct 05, 2023
Product Description
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
Batch or Lot Expiration Information
Lot# A200170, exp. date December 2023
Affected Packages Involved in this Recall
68180-658-06Product
68180-658-01Product
68180-659-06Product
68180-659-07Product
68180-659-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
