Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90037

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

Open FDA event record

Event summary

Timeline bucket
April 15, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Macleods Pharma Usa 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

6 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 6

Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

D-0832-2022
Recall number
D-0832-2022
Initiated
April 15, 2022
Classification
Class II
Status
Terminated
Recalling firm
Macleods Pharma Usa Inc
Quantity
12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
AZIDO Impurity
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- AZIDO Impurity levels observed to be above acceptable limits

Code information

Lot # BLH2002A, exp. date 11/2022 BLH2003B, exp. date 11/2022 BLH2004A, exp. date 11/2022

Distribution pattern

Product was distributed nationwide.

drug · product 2 of 6

Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

D-0833-2022
Recall number
D-0833-2022
Initiated
April 15, 2022
Classification
Class II
Status
Terminated
Recalling firm
Macleods Pharma Usa Inc
Quantity
3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
AZIDO Impurity
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- AZIDO Impurity levels observed to be above acceptable limits

Code information

Lot # BLI2002A, exp. date 11/2022 BLI2004A, exp. date 11/2022 BLI2104B, exp. date 05/2023

Distribution pattern

Product was distributed nationwide.

drug · product 3 of 6

Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

D-0834-2022
Recall number
D-0834-2022
Initiated
April 15, 2022
Classification
Class II
Status
Terminated
Recalling firm
Macleods Pharma Usa Inc
Quantity
3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
AZIDO Impurity
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- AZIDO Impurity levels observed to be above acceptable limits

Code information

Lot # BLI2107B, exp. date 06/2023 BLI2101A, exp. date 12/2022 BLI2103A, exp. date 12/2022 BLI2105A, exp. date 05/2023

Distribution pattern

Product was distributed nationwide.

drug · product 4 of 6

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

D-0835-2022
Recall number
D-0835-2022
Initiated
April 15, 2022
Classification
Class II
Status
Terminated
Recalling firm
Macleods Pharma Usa Inc
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
AZIDO Impurity
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- AZIDO Impurity levels observed to be above acceptable limits

Code information

Lot # BLK2107B, exp. date 05/2023 BLK2101A, exp. date 01/2025 BLK2102A, exp. date 02/2025 BLK2103B, exp. date 02/2023 BLK2103C, exp. date 02/2023 BLK2104A, exp. date 05/2023

Distribution pattern

Product was distributed nationwide.

drug · product 5 of 6

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

D-0836-2022
Recall number
D-0836-2022
Initiated
April 15, 2022
Classification
Class II
Status
Terminated
Recalling firm
Macleods Pharma Usa Inc
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
AZIDO Impurity
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- AZIDO Impurity levels observed to be above acceptable limits

Code information

Lot # BLM2106B, exp. date 05/2023 BLM2101A, exp. date 01/2025 BLM2102A, exp. date 02/2023 BLM2106A, exp. date 05/2023 BLM2103B, exp. date 02/2023 BLM2104A, exp. date 05/2023 BLM2110A, exp. date 06/2023

Distribution pattern

Product was distributed nationwide.

drug · product 6 of 6

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

D-0837-2022
Recall number
D-0837-2022
Initiated
April 15, 2022
Classification
Class II
Status
Terminated
Recalling firm
Macleods Pharma Usa Inc
Quantity
N/A

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
AZIDO Impurity
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- AZIDO Impurity levels observed to be above acceptable limits

Code information

Lot # BLL2107B, exp. date 05/2023 BLL2101A, exp. date 01/2025 BLL2102A, exp. date 02/2025 BLL2103B, exp. date 02/2023 BLL2104A, exp. date 05/2023

Distribution pattern

Product was distributed nationwide.