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SUN PHARMACEUTICAL INDUSTRIES INC

SUN PHARMACEUTICAL INDUSTRIES INC Recalls

All product recalls associated with SUN PHARMACEUTICAL INDUSTRIES INC.

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Recall Summary

Total Recalls

1000

Past Year

303

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 961–980 of 4747 recalls

Medroxyprogesterone Acetate (Sun Pharma) – Sterility Risk (2022)

Lack of assurance of sterility

Class IIModerate

FDAMay 6, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Losartan Potassium & HCTZ Tablets (Preferred Pharmaceuticals) – AZIDO Impurity High (2022)

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

Class IIModerate

FDAMay 3, 2022CA, FL, IN• Preferred Pharmaceuticals, Inc.

Losartan Potassium & HCTZ Tablets (Preferred Pharmaceuticals) – AZIDO Impurity High (2022)

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

Class II

1...47 484950 51...238

Page 49 of 238Next

Moderate

FDAMay 3, 2022CA, FL, IN• Preferred Pharmaceuticals, Inc.

Bupropion Hydrochloride Tablets (Sun Pharmaceutical) – Foreign Substance (2022)

Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

Class IIILow

FDAApr 29, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Bupropion Hydrochloride Tablets (Sun Pharmaceutical) – Foreign Substance (2022)

Class IIILow

FDAApr 29, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Axium Detachable Coil System (Micro Therapeutics) – labeling error (2022)

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

FDAApr 27, 2022IN• Micro Therapeutics, Inc.

GaviLyte-C (Lupin Pharmaceuticals) – Stability Specification (2022)

Failed Stability Specification

Class IIModerate

FDAApr 27, 2022Nationwide• Lupin Pharmaceuticals Inc.

TEG 5000 Fibrinogen Reagent (Haemonetics) – reference range (2022)

Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.

FDAApr 26, 2022Nationwide• Haemonetics Corporation

Norepinephrine Solution (SCA Pharmaceuticals) – CGMP Deviation (2022)

CGMP Deviations

Class IIModerate

FDAApr 25, 2022Nationwide• SCA Pharmaceuticals

Zonisamide Capsules 50mg (Glenmark) – CGMP Deviation (2022)

cGMP deviations

Class IIModerate

FDAApr 25, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Fentanyl/Bupivacaine Solution (SCA Pharmaceuticals) – CGMP Deviation (2022)

CGMP Deviations

Class IIModerate

FDAApr 25, 2022Nationwide• SCA Pharmaceuticals

Vancomycin HCl Solution (SCA Pharmaceuticals) – CGMP Deviation (2022)

CGMP Deviations

Class IIModerate

FDAApr 25, 2022Nationwide• SCA Pharmaceuticals

Zonisamide Capsules 100mg (Glenmark) – CGMP Deviation (2022)

cGMP deviations

Class IIModerate

FDAApr 25, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

Zonisamide Capsules 25mg (Glenmark) – CGMP Deviation (2022)

cGMP deviations

Class IIModerate

FDAApr 25, 2022Nationwide• Glenmark Pharmaceuticals Inc., USA

TEG5000 Analyzer (Haemonetics) – software calculation error (2022)

When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.

FDAApr 19, 2022Nationwide• Haemonetics Corporation