Cefixime Powder, For Suspension
FDA Recall NDC 68180-405
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Cefixime (NDC 68180-405). A significant event, classified as Class II, was initiated on Aug 21, 2024 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study."
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
August 2024 Class II Recall: Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Recall Number
Class II Terminated
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Aug 21, 2024
Sep 04, 2024
4554 bottles
Recall Profile & Regulatory Data
Event ID
95193
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Apr 29, 2025
Product Description
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Batch or Lot Expiration Information
Lot# : F201517, Exp 11/30/2024
Affected Packages Involved in this Recall
68180-405-01Product
68180-407-03Product
68180-407-04Product
68180-416-08Product
68180-416-11Product
68180-423-11Product
68180-423-08Product
Class II Terminated
Failed Content Uniformity Specifications
May 30, 2024
Jun 26, 2024
3,552 bottles
Recall Profile & Regulatory Data
Event ID
94723
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Apr 29, 2025
Product Description
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03
Batch or Lot Expiration Information
Lot# Lot F201519, Expiry: November 2024
Affected Packages Involved in this Recall
68180-405-01Product
68180-407-03Product
68180-407-04Product
68180-416-08Product
68180-416-11Product
68180-423-11Product
68180-423-08Product
January 2024 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications
Jan 03, 2024
Feb 07, 2024
4,608 Bottles
Recall Profile & Regulatory Data
Event ID
93730
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 27, 2024
Product Description
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Batch or Lot Expiration Information
Lot# : F304833, Exp 06/2025
Affected Packages Involved in this Recall
68180-405-01Product
68180-407-03Product
68180-407-04Product
68180-416-08Product
68180-416-11Product
68180-423-11Product
68180-423-08Product
Class II Terminated
Subpotent Drug
Apr 29, 2021
May 26, 2021
3,138 bottles
Recall Profile & Regulatory Data
Event ID
87871
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Feb 22, 2022
Product Description
Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01
Batch or Lot Expiration Information
Lot# : F900787, Exp. Date 4/2021
Affected Packages Involved in this Recall
68180-405-01Product
68180-407-03Product
68180-407-04Product
68180-416-08Product
68180-416-11Product
68180-423-11Product
68180-423-08Product
Class II Terminated
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Apr 15, 2020
Apr 29, 2020
4,518 bottles
Recall Profile & Regulatory Data
Event ID
85487
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide with the United States and Puerto Rico.
Termination Date
Jun 07, 2021
Product Description
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
Batch or Lot Expiration Information
Lot# : F800779, Expiry 4/2020
Affected Packages Involved in this Recall
68180-405-01Product
68180-407-03Product
68180-407-04Product
68180-416-08Product
68180-416-11Product
68180-423-11Product
68180-423-08Product
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.
