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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88856

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 12, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Lupin Pharmaceuticals Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 5

Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only

D-0086-2022
Recall number
D-0086-2022
Initiated
October 12, 2021
Classification
Class II
Status
Terminated
Quantity
51,144 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity N-nitrosoirbesartan detected in API
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Code information

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

Distribution pattern

Product was distributed to major distributors who may have further distributed the product nationwide.

drug · product 2 of 5

Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only

D-0087-2022
Recall number
D-0087-2022
Initiated
October 12, 2021
Classification
Class II
Status
Terminated
Quantity
134,016 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity N-nitrosoirbesartan detected in API
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Code information

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

Distribution pattern

Product was distributed to major distributors who may have further distributed the product nationwide.

drug · product 3 of 5

Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only

D-0088-2022
Recall number
D-0088-2022
Initiated
October 12, 2021
Classification
Class II
Status
Terminated
Quantity
119,544 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity N-nitrosoirbesartan detected in API
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Code information

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

Distribution pattern

Product was distributed to major distributors who may have further distributed the product nationwide.

drug · product 4 of 5

Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only

D-0089-2022
Recall number
D-0089-2022
Initiated
October 12, 2021
Classification
Class II
Status
Terminated
Quantity
63,408 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity N-nitrosoirbesartan detected in API
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Code information

a) Lot# H804537, exp. date 30/09/2021 H805148, exp. date 31/10/2021 H900063, exp. date 31/10/2021 H900522, exp. date 31/12/2021 H901582, exp. date 31/01/2022 b) Lot# H000963, exp. date 30/04/2022 H804507, exp. date 30/04/2022 H804536, exp. date 30/09/2021 H805070, exp. date 31/10/2021 H805149, exp. date 31/10/2021 H900064, exp. date 31/12/2021 H900523, exp. date 31/01/2022 H901583, exp. date 30/04/2022 H902530, exp. date 30/04/2022

Distribution pattern

Product was distributed to major distributors who may have further distributed the product nationwide.

drug · product 5 of 5

Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only

D-0090-2022
Recall number
D-0090-2022
Initiated
October 12, 2021
Classification
Class II
Status
Terminated
Quantity
98,052 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity N-nitrosoirbesartan detected in API
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: impurity N-nitrosoirbesartan detected in API

Code information

a) Lot# H804192, exp. date 31/08/2021 H805348, exp. date 30/11/2021 H900065, exp. date 31/12/2021 H902264; exp. date 31/05/2022 b) Lot# H804082, exp. date 31/08/2021 H804121, exp. date 31/08/2021 H804338, exp. date 31/08/2021 H804538, exp. date 30/09/2021 H804539, exp. date 30/09/2021 H805349, exp. date 30/11/2021 H805350, exp. date 30/11/2021 H900066, exp. date 31/12/2021 H900067, exp. date 31/12/2021 H902265, exp. date31/05/2022 H902275, exp. date31/05/2022 H902276, exp. date31/05/2022 H902531, exp. date 30/04/2022 H902532, exp. date 30/04/2022

Distribution pattern

Product was distributed to major distributors who may have further distributed the product nationwide.