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Showing 101–120 of 505 results

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Gabapentin Capsules (Harvard Drug) – impurity specification failure (2025)

Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

Class IIModerate

FDAOct 10, 2025Nationwide• The Harvard Drug Group LLC

Fesoterodine Tablets (Alembic) – Impurity Levels (2025)

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

FDAOct 10, 2025Nationwide• Alembic Pharmaceuticals Limited

Everolimus Tablets 5mg (Endo USA) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

FDAOct 10, 2025Nationwide• Endo USA, Inc.

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.

Sucralfate Tablets (Amerisource) – Quality Management (2025)

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Class IIModerate

FDAOct 9, 2025Nationwide• Amerisource Health Services LLC

Olopatadine Ophthalmic Solution (USV) – Impurity Concern (2025)

Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.

Class IIModerate

FDAOct 9, 2025Nationwide• USV Private Limited

Fasenra Injection (AstraZeneca) – Sterility Risk (2025)

Lack of Assurance of Sterility:

Class IIModerate

FDAOct 8, 2025Nationwide• ASTRAZENECA PHARMACEUTICALS

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

Carbidopa Levodopa Entacapone Tablets (Rising Pharma) – Product Mix-up (2025)

Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).

Class IIModerate

FDAOct 7, 2025Nationwide• Rising Pharma Holding, Inc.

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

Tavaborole Topical Solution 5% (Viona) – Discoloration (2025)

Discoloration

Class IIModerate

FDAOct 6, 2025Nationwide• VIONA PHARMACEUTICALS INC

Desipramine Tablets 50mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 10mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 25mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 150mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 75mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 100mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Ketorolac Injection (Aspiro Pharma) – Glass Particulate (2025)

Presence of Particulate Matter: Particulate matter identified as glass

Class IIModerate

FDAOct 1, 2025Nationwide• Aspiro Pharma Limited

Doxycycline Hyclate Tablets 100mg (Acella) – Dissolution Failure (2025)

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

Class IIModerate

FDASep 29, 2025Nationwide• Acella Pharmaceuticals, LLC

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