Losartan Potassium Tablet
FDA Recall NDC 68180-211
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Losartan Potassium (NDC 68180-211). A significant event, classified as Class II, was initiated on Mar 31, 2022 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits"
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
March 2022 Class II Recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall Number
Class II Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Mar 31, 2022
May 11, 2022
1,247,067 bottles
Recall Profile & Regulatory Data
Event ID
89916
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide
Termination Date
May 22, 2023
Product Description
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
Batch or Lot Expiration Information
Lot# H903573, exp. date Oct-22 H002311, exp. date Dec-22 H100713, exp. date Mar-23 H001060, exp. date Nov-22 H002620, exp. date Jan-23 H100714, exp. date Mar-23 H001456, exp. date Nov-22 H002313, exp. date Jan-23 H100934, exp. date Mar-23 H001457, exp. date Nov-22 H002490, exp. date Jan-23 H100935, exp. date Mar-23 H001470,, exp. date Nov-22 H002842, exp. date Jan-23 H101081, exp. date Mar-23 H001484, exp. date Dec-22 H002843, exp. date Jan-23 H101148, exp. date Mar-23 H001485, exp. date Dec-22 H002995, exp. date Jan-23 H101639, exp. date Mar-23 H001708, exp. date Dec-22 H003199, exp. date Feb-23 H101480, exp. date Mar-23 H002314, exp. date Dec-22 H003200, exp. date Feb-23 H101822, exp. date Mar-23 H001709, exp. date Dec-22 H100028, exp. date Feb-23 H101481, exp. date Mar-23 H002001, exp. date Dec-22 H100712, exp. date Feb-23 H102288, exp. date Mar-23 H001991, exp. date Dec-22 H100221, exp. date Feb-23 H002000, exp. date Dec-22 H100222, exp. dateFeb-23 H903582, exp. date Oct-22 H001707, exp. dateDec-22 H100220, exp. date Feb-23 H000556,, exp. date Nov-22 H003045, exp. date Dec-22 H100901, exp. date Mar-23 H000557, exp. date Nov-22 H002391, exp. date Dec-22 H101078, exp. date Mar-23 H001061, exp. date Nov-22 H002312, exp. date Jan-23 H101479, exp. date Mar-23 H001062, exp. date Nov-22 H002517, exp. date Jan-23 H101496, exp. date Mar-23 H001431, exp. date Nov-22 H002841, exp. date Jan-23 H101821, exp. date Mar-23 H002341, exp. date Nov-22 H003044, exp. date Feb-23 H102286, exp. date Mar-23 H001706, exp. date Dec-22 H003198, exp. date Feb-23 H102287, exp. date Mar-23
Affected Packages Involved in this Recall
68180-210-09Product
68180-210-03Product
68180-210-01Product
68180-210-06Product
68180-211-06Product
68180-211-09Product
68180-211-03Product
68180-211-01Product
68180-212-06Product
68180-212-03Product
68180-212-09Product
68180-212-01Product
68180-376-03Product
68180-376-06Product
68180-376-01Product
68180-376-09Product
68180-377-03Product
68180-377-01Product
68180-377-09Product
68180-377-06Product
68180-378-09Product
68180-378-03Product
68180-378-06Product
68180-378-01Product
68180-307-01Product
68180-307-02Product
68180-307-09Product
68180-307-06Product
68180-308-06Product
68180-308-09Product
68180-308-02Product
68180-308-01Product
68180-309-06Product
68180-309-09Product
68180-309-02Product
68180-309-01Product
March 2022 Class II Recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall Number
Class II Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Mar 31, 2022
May 11, 2022
1,466,150 bottles
Recall Profile & Regulatory Data
Event ID
89916
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide
Termination Date
May 22, 2023
Product Description
Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
Batch or Lot Expiration Information
Lot# H903720, exp. date Oct-22 H001876, exp. date Dec-22 H003002, exp. date Jan-23 H903774, exp. date Oct-22 H001877, exp. date Dec-22 H003003, exp. date Feb-23 H000849, exp. date Nov-22 H002127, exp. date Dec-22 H003004, exp. date Feb-23 H001412, exp. date Nov-22 H002128, exp. date Dec-22 H003123, exp. date Feb-23 H001413, exp. date Nov-22 H002643, exp. date Jan-23 H003124, exp. date Feb-23 H001414, exp. date Nov-22 H002644, exp. date Jan-23 H101129, exp. date Feb-23 H001430, exp. date Nov-22 H002645, exp. date Jan-23 H101147, exp. date Mar-23 H001526, exp. date Dec-22 H002839, exp. date Jan-23 H102139, exp. date Mar-23 H001652, exp. date Dec-22 H002840, exp. date Jan-23 H102158, exp. date Mar-23 H000605, exp. date Jan-23 H001599, exp. date Dec-22 H100148, exp. date Feb-23 H001401, exp. date Nov-22 H001875, exp. date Dec-22 H102043, exp. date Mar-23 H001063, exp. date Nov-22 H002126, exp. date Dec-22 H101495, exp. date Mar-23 H001188, exp. date Nov-22 H002838, exp. date Jan-23 H001455, exp. date Nov-22 H002642, exp. date Jan-23
Affected Packages Involved in this Recall
68180-210-09Product
68180-210-03Product
68180-210-01Product
68180-210-06Product
68180-211-06Product
68180-211-09Product
68180-211-03Product
68180-211-01Product
68180-212-06Product
68180-212-03Product
68180-212-09Product
68180-212-01Product
68180-376-03Product
68180-376-06Product
68180-376-01Product
68180-376-09Product
68180-377-03Product
68180-377-01Product
68180-377-09Product
68180-377-06Product
68180-378-09Product
68180-378-03Product
68180-378-06Product
68180-378-01Product
68180-307-01Product
68180-307-02Product
68180-307-09Product
68180-307-06Product
68180-308-06Product
68180-308-09Product
68180-308-02Product
68180-308-01Product
68180-309-06Product
68180-309-09Product
68180-309-02Product
68180-309-01Product
March 2022 Class II Recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall Number
Class II Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Mar 31, 2022
May 11, 2022
657,336 bottles
Recall Profile & Regulatory Data
Event ID
89916
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide
Termination Date
May 22, 2023
Product Description
Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
Batch or Lot Expiration Information
Lot# H001333, exp. date Nov-22 H002786, exp. date Jan-23 H101282, exp. date Feb-23 H001189, exp. date Nov-22 H002955, exp. date Jan-23 H101285, exp. date Feb-23 H001714, exp. date Dec-22 H000523, exp. date Jan-23 H101989, exp. date Mar-23 H001940, exp. date Dec-22 H003080, exp. date Jan-23 H101789, exp. date Mar-23 H002388, exp. date Jan-23 H100109, exp. date Feb-23 H002389, exp. date Jan-23 H100642, exp. date Feb-23 H000848, exp. date Nov-22, H002002, exp. date Dec-22 H100110, exp. date Feb-23 H001190, exp. date Nov-22 H002003, exp. date Dec-22 H100111, exp. date Feb-23 H001191, exp. date Nov-22 H002489, exp. date Jan-23 H100146, exp. date Feb-23 H001192, exp. date Nov-22 H002390, exp. date Jan-23 H100147, exp. date Feb-23 H001058, exp. date Nov-22 H002486, exp. date Jan-23 H101283, exp. date Feb-23 H000985, exp. date Nov-22 H002487, exp. date Jan-23 H101284, exp. date Feb-23 H001059, exp. date Nov-22 H002488, exp. date Jan-23 H100643, exp. date Feb-23 H001275, exp. date Nov-22 H002787, exp. date Jan-23 H100644, exp. date Mar-23 H001715, exp. date Dec-22 H002957, exp. date Jan-23 H100869, exp. date Mar-23 H001716, exp. date Dec-22 H002958, exp. date Jan-23 H101990, exp. date Mar-23 H001717, exp. date Dec-22 H003079, exp. date Jan-23 H101991, exp. date Mar-23 H001718, exp. date Dec-22 H003121, exp. date Feb-23 H101992, exp. date Mar-23 H001941, exp. date Dec-22 H003122, exp. date Feb-23 H000847, exp. date Nov 2022
Affected Packages Involved in this Recall
68180-210-09Product
68180-210-03Product
68180-210-01Product
68180-210-06Product
68180-211-06Product
68180-211-09Product
68180-211-03Product
68180-211-01Product
68180-212-06Product
68180-212-03Product
68180-212-09Product
68180-212-01Product
68180-376-03Product
68180-376-06Product
68180-376-01Product
68180-376-09Product
68180-377-03Product
68180-377-01Product
68180-377-09Product
68180-377-06Product
68180-378-09Product
68180-378-03Product
68180-378-06Product
68180-378-01Product
68180-307-01Product
68180-307-02Product
68180-307-09Product
68180-307-06Product
68180-308-06Product
68180-308-09Product
68180-308-02Product
68180-308-01Product
68180-309-06Product
68180-309-09Product
68180-309-02Product
68180-309-01Product
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.
