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Esomeprazole Magnesium Suspension 40mg (Zydus) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

Class IIModerate

FDAMay 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Celecoxib Capsules (AvKARE) – Foreign Tablet Contamination (2025)

Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

Class IIModerate

FDAMay 13, 2025Nationwide

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Esomeprazole Magnesium Suspension 40mg (Zydus) – Impurity Specification (2025)

Celecoxib Capsules (AvKARE) – Foreign Tablet Contamination (2025)

Phentermine Hydrochloride Capsules (KVK Tech) – Manufacturing Deviation (2025)

Indomethacin Extended-Release Capsules (KVK Tech) – Manufacturing Deviation (2025)

Celecoxib Capsules (Alembic) – Foreign Tablet Contamination (2025)

Chlorthalidone Tablets (AvKARE) – Dissolution Specification Failure (2025)

Bromfenac Ophthalmic Solution (Alembic) – Impurity Specification Failure (2025)

Endurance Boost Capsules (EnShiShiXiangNi) – Undeclared Sildenafil (2025)

Testosterone Cypionate Injection (Empower Pharmacy) – Sterility Risk (2025)

Kids Multivitamin Gummies (Nordic Naturals) – Mislabeled Product (2025)

Testosterone Pellet 200 mg (BSO LLC) – Glass Particle Contamination (2025)

Testosterone Pellet 100mg (BSO) – Particulate Matter Risk (2025)

Testosterone Pellet 200 mg (BSO LLC) – Glass Particle Contamination (2025)

Testosterone Pellet 200mg (BSO) – Particulate Matter Risk (2025)

Testosterone Pellet 200 mg (BSO LLC) – Glass Particle Contamination (2025)

Medroxyprogesterone Acetate Injection (Mckesson) – Cold Chain Transit Delay (2025)

Infuvite Adult Vitamins (Mckesson) – Cold Chain Transit Delay (2025)

Artridon Glucosamine (Kenil Healthcare) - CGMP Issues (2025)

Kofal Pain Relief Ointment (Kenil) – CGMP Deviation (2025)

Optim V Anti-Itch Cream (Kenil Healthcare) - CGMP Issues (2025)