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Macleods Pharma Usa Inc

Macleods Pharma Usa Inc Recalls

All product recalls associated with Macleods Pharma Usa Inc.

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Recall Summary

Total Recalls

1000

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 641–660 of 2399 recalls

Losartan/Hydrochlorothiazide (Macleods) - Impurity Levels (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAJun 10, 2022Nationwide• Macleods Pharma Usa Inc

Fresenius Medical Care Holdings, Inc.: NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3

The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.

FDAJun 1, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in p...

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

1...31 323334 35...120

Page 33 of 120Next

FDAMay 31, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc.: NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in p...

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

FDAMay 31, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Tegsedi Injection (Akcea) – Superpotent Formulation (2022)

Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).

Class IHigh

FDAMay 23, 2022KY• Akcea Therapeutics, Inc.

Agilent Technologies, Inc.: Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), ...

Label provided for substrate vail contained incorrect expiration date.

FDAMay 20, 2022Nationwide• Agilent Technologies, Inc.

Frigo Mozzarella Cheese (Saputo) – Undeclared milk (2022)

The 2 lb. units of Frigo Low Moisture Part-Skim Mozzarella Cheese are being recalled due to the allergen of milk in the product not being declared on the label.

Class IIModerate

FDAMay 20, 2022AZ, CA, CO +1 more• Saputo Cheese USA Inc.

MicroPort Orthopedics Inc.: PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.

FDAMay 4, 2022Nationwide• MicroPort Orthopedics Inc.

Fresenius Medical Care Holdings, Inc.: Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

FDAMay 4, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Micro Therapeutics, Inc.: AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium De...

Due to incorrect size and configuration labeling of the detachable coil system.

FDAApr 27, 2022IN• Micro Therapeutics, Inc.

Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Seocho-Daero, Seocho # 413 398 Platinum Tower Seoul Korea (the Republic of): ProudP Everyday Uroflow Tracker Software Version 1.x.x S...

Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower urination volume and velocity values than expected.

FDAApr 21, 2022Nationwide• Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Seocho-Daero, Seocho # 413 398 Platinum Tower Seoul Korea (the Republic of)

Losartan Potassium Tablets (Macleods) – Impurity Levels High (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAApr 15, 2022Nationwide• Macleods Pharma Usa Inc

Losartan Potassium Tablets (Macleods) – Impurity Levels High (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAApr 15, 2022Nationwide• Macleods Pharma Usa Inc

Losartan Potassium Tablets (Macleods) – Impurity Levels High (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAApr 15, 2022Nationwide• Macleods Pharma Usa Inc

Losartan Hydrochlorothiazide (Macleods) – Impurity Levels High (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAApr 15, 2022Nationwide• Macleods Pharma Usa Inc

Losartan Hydrochlorothiazide (Macleods) – Impurity Levels High (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAApr 15, 2022Nationwide• Macleods Pharma Usa Inc

Losartan Hydrochlorothiazide (Macleods) – Impurity Levels High (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAApr 15, 2022Nationwide• Macleods Pharma Usa Inc

Northgate Technologies, Inc.: AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithot...

Product labeled incorrectly.

FDAApr 13, 2022Nationwide• Northgate Technologies, Inc.

Methylprednisolone Tablets (Jubilant Cadista) – Subpotent Medication (2022)

Subpotent

Class IIILow

FDAApr 1, 2022Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Clinician's Choice Dental Products Inc.: Affinity Hydroactive Impression Material Heavy Body Regul...

Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK

FDAMar 18, 2022IN, SC• Clinician's Choice Dental Products Inc.