Irbesartan Tablet
FDA Recall NDC 68180-412

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 Irbesartan (NDC 68180-412). A significant event, classified as Class II, was initiated on Oct 12, 2021 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP Deviations: impurity N-nitrosoirbesartan detected in API"

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

D-0086-2022TERMINATEDD-0088-2022TERMINATEDD-0087-2022TERMINATED

October 2021 Class II Recall: CGMP Deviations

Recall Number
D-0086-2022
Class II Terminated
Reason for Recall
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Initiated
Oct 12, 2021
Reported
Nov 10, 2021
Quantity
51,144 bottles

Recall Profile & Regulatory Data

Event ID
88856
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to major distributors who may have further distributed the product nationwide.
Termination Date
Jan 30, 2023
Product Description
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Batch or Lot Expiration Information
Lot# a)
Lot# H000843, exp. date 28/02/2023 H805727, exp. date 30/11/2021 H901579, exp. date 31/03/2022 b)
Lot# H000844, exp. date 28/02/2023 H000964, exp. date 31/03/2023 H804311, exp. date 31/08/2021 H805267, exp. date 30/11/2021 H805268, exp. date 30/11/2021 H805269, exp. date 30/11/2021 H805725, exp. date 30/11/2021 H805726, exp. date 30/11/2021 H901497, exp. date 31/01/2022 H901577, exp. date 31/03/2022 H901578, exp. date 31/03/2022 H902258, exp. date 31/05/2022
Affected Packages Involved in this Recall
68180-410-06Product
68180-410-09Product
68180-411-02Product
68180-411-06Product
68180-411-09Product
68180-412-02Product
68180-412-06Product
68180-412-09Product

October 2021 Class II Recall: CGMP Deviations

Recall Number
D-0088-2022
Class II Terminated
Reason for Recall
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Initiated
Oct 12, 2021
Reported
Nov 10, 2021
Quantity
119,544 bottles

Recall Profile & Regulatory Data

Event ID
88856
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to major distributors who may have further distributed the product nationwide.
Termination Date
Jan 30, 2023
Product Description
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Batch or Lot Expiration Information
Lot# a)
Lot# H804310, exp. date 31/08/2021 H900050, exp. date 30/11/2021 H902262, exp. date 31/05/2022 b)
Lot# H000845, exp. date 28/02/2023 H000846, exp. date 28/02/2023 H000965, exp. date 31/03/2023 H805345, exp. date 30/11/2021 H805346, exp. date 30/11/2021 H805347, exp. date 30/11/2021 H805724, exp. date 30/11/2021 H900061, exp. date 31/12/2021 H900062, exp. date 31/12/2021 H900445, exp. date 31/01/2022 H901489, exp. date 31/03/2022 H901490, exp. date 31/03/2022 H901491, exp. date 31/03/2022 H902261, exp. date 31/05/2022
Affected Packages Involved in this Recall
68180-410-06Product
68180-410-09Product
68180-411-02Product
68180-411-06Product
68180-411-09Product
68180-412-02Product
68180-412-06Product
68180-412-09Product

October 2021 Class II Recall: CGMP Deviations

Recall Number
D-0087-2022
Class II Terminated
Reason for Recall
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Initiated
Oct 12, 2021
Reported
Nov 10, 2021
Quantity
134,016 bottles

Recall Profile & Regulatory Data

Event ID
88856
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to major distributors who may have further distributed the product nationwide.
Termination Date
Jan 30, 2023
Product Description
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
Batch or Lot Expiration Information
Lot# a)
Lot# H804403, exp. date 31/08/2021 H805251, exp. date 30/11/2021 H805640, exp. date 30/11/2021 H901580; exp. date 30/04/2022 b)
Lot# H804492, exp. date 31/08/2021 H805252, exp. date 30/11/2021 H805253, exp. date30/11/2021 H805641, exp. date30/11/2021 H805642, exp. date30/11/2021 H805643, exp. date 30/11/2021 H901581, exp. date 30/04/2021 H902139, exp. date 30/04/2022 H902140, exp. date 30/04/2022
Affected Packages Involved in this Recall
68180-410-06Product
68180-410-09Product
68180-411-02Product
68180-411-06Product
68180-411-09Product
68180-412-02Product
68180-412-06Product
68180-412-09Product

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.