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Ezetimibe and Simvastatin Tablets (Glenmark) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.

Class IIILow

FDAMay 19, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Instant Milk Tea Honeydew (R&M Trading) – Undeclared Milk (2025)

The Instant Milk Tea Powder's ingredients statement declares Non-Dairy Creamer (Whey Powder, Sodium Caseinate) but does not specify milk.

Class IIILow

FDAMay 12, 2025Nationwide

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Ezetimibe and Simvastatin Tablets (Glenmark) – Impurity Specification Failure (2025)

Instant Milk Tea Honeydew (R&M Trading) – Undeclared Milk (2025)

Instant Milk Tea Taro (R&M Trading) – Undeclared Milk (2025)

Instant Milk Tea Matcha (R&M Trading) – Undeclared Milk (2025)

Instant Milk Tea Brown Sugar (R&M Trading) – Undeclared Milk (2025)

Instant Milk Tea Original (R&M Trading) – Undeclared Milk (2025)

Nutritional Yeast Powder (Now Foods) – Packaging Error (2025)

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

NutriLean (Legere Pharmaceuticals) – Undeclared Colors (2025)

Super ProTHIN Plus (Legere Pharmaceuticals) – Undeclared Colors (2025)

Probese Caps (Legere Pharmaceuticals) – Undeclared Colors (2025)

Prothin Dietary Supplement (Legere Pharmaceuticals) – undeclared colors (2025)

Rodex Forte Supplement (Legere Pharmaceuticals) – undeclared colors (2025)

Protrim Plus Supplement (Legere Pharmaceuticals) – undeclared colors (2025)

GNC Women's 30+ Vitapak (GNC Holdings) – Undeclared Fish Allergen (2025)

HYDROmorphone Hydrochloride (OurPharma) – Superpotent Drug (2025)

Cabot Creamery Butter (AGRI-MARK) – bacterial contamination (2025)

Farmer House Olive Strips (Lins Waha) – Contains Cyclamates (2025)

Gabapentin Capsules (Sun Pharmaceutical) – Cross Contamination (2025)

Gabapentin Capsules (Sun Pharmaceutical) – Cross Contamination (2025)