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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

304

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 41–60 of 4747 recalls

Lisdexamfetamine 60mg Capsules (Sun) - Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Class IIModerate

FDAOct 28, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Bromocriptine Capsules (Zydus) - Impurity Deviation (2025)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.

Class IIModerate

FDAOct 23, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Clomipramine 75mg Capsules (Zydus) - Nitrosamine Risk (2025)

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

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Class IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Clomipramine 25mg Capsules (Zydus) - Nitrosamine Risk (2025)

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Class IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Clomipramine 50mg Capsules (Zydus) - Nitrosamine Risk (2025)

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Class IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

BioFire Respiratory Panel 2.1 (BioFire) – False Negative Risk (2025)

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

FDAOct 22, 2025Nationwide• BioFire Diagnostics, LLC

VerifyNow PRUTest (Accriva) – Unauthorized Device Distribution (2025)

Due to an device without a premarket clearance being incorrectly package and distributed.

FDAOct 21, 2025Nationwide• Accriva Diagnostics, Inc.

Amoxicillin Clavulanate Suspension (Teva) – subpotent drug (2025)

Subpotent drug; Clavulanate Potassium component

Class IIModerate

FDAOct 13, 2025CA, IN, MS +1 more• Teva Pharmaceuticals USA, Inc

Fesoterodine Tablets (Alembic) – Impurity Levels (2025)

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

Class IIILow

FDAOct 10, 2025Nationwide• Alembic Pharmaceuticals Limited

Duloxetine Capsules 60mg (Breckenridge) – Impurity Concerns (2025)

CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

Class IIModerate

FDAOct 9, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Fasenra Injection (AstraZeneca) – Sterility Risk (2025)

Lack of Assurance of Sterility:

Class IIModerate

FDAOct 8, 2025Nationwide• ASTRAZENECA PHARMACEUTICALS

Prazosin Hydrochloride Capsules 2mg (Teva) – Impurity Concerns (2025)

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

Class IIModerate

FDAOct 7, 2025Nationwide• Teva Pharmaceuticals USA, Inc

Prazosin Hydrochloride Capsules 5mg (Teva) – Impurity Concerns (2025)

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

Class IIModerate

FDAOct 7, 2025Nationwide• Teva Pharmaceuticals USA, Inc

Prazosin Hydrochloride Capsules 1mg (Teva) – Impurity Concerns (2025)

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

Class IIModerate

FDAOct 7, 2025Nationwide• Teva Pharmaceuticals USA, Inc

3gAllergy IgE Kit (Siemens) – barcode scanning error (2025)

The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.

FDAOct 6, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.