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Metoprolol Succinate Tablets 25mg (Granules) – Dissolution Specification Failure (2025)

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

Class IIModerate

FDAJun 24, 2025Nationwide• Granules Pharmaceuticals Inc.

Lithium Orotate Supplement (Weyland Brain) – Potency Mismatch (2025)

Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.

Class IIILow

FDAJun 24, 2025Nationwide

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Metoprolol Succinate Tablets 25mg (Granules) – Dissolution Specification Failure (2025)

Lithium Orotate Supplement (Weyland Brain) – Potency Mismatch (2025)

LVP Blood Products Set (Fresenius Kabi) – Cassette Leak (2025)

PILLAR SA Ti Implant (Orthofix) – Labeling Discrepancy (2025)

Lithium Orotate 5MG (Enjoy Nutrition) – Potency Issue (2025)

Lithium Orotate Capsules (GMP Laboratories) – Manufacturing Specification (2025)

Lithium Orotate Capsules (GMP Laboratories) – Manufacturing Specification (2025)

Lithium Orotate 10MG (Enjoy Nutrition) – Potency Issue (2025)

Astra EV Digital Analog (Preat) – Rotational Misalignment (2025)

Lithium Orotate 2.5MG (Enjoy Nutrition) – Potency Issue (2025)

LVP Primary Administration Set (Fresenius Kabi) – Cassette Leak (2025)

HeartMate Power Unit (Thoratec) – Power Cord Locking (2025)

Nellcor SpO2 Monitor (Covidien) – Alarm Functionality (2025)

Dual Flat Panel Monitor (Steris) – Yoke Assembly Risk (2025)

BD COR System Software (Becton Dickinson) – Functionality Issue (2025)

Impella Controller (Abiomed) – Pump Detection Problem (2025)

Golden Raisins (Nirwana Foods) – Undeclared Sulfites (2025)

Tahini Dip (Shovel and Spoon) – Spoilage Risk (2025)

Levothyroxine Sodium Tablets 25mcg (Accord) – Subpotent Drug (2025)

Guedel Airway Size 3 (Intersurgical) – Contamination Risk (2025)