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Showing 1–20 of 3325 results

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Merck Emend (Merck) – Metal Particulate Risk (2025)

Presence of particulate matter: potential presence of metal particulates in the product.

Class II

FDADec 12, 2025Nationwide• Merck Sharp & Dohme LLC

Noxafil Powdermix (Merck) – Metal Particulate Risk (2025)

Presence of particulate matter: potential presence of metal particulates in the product.

Class II

FDADec 12, 2025Nationwide• Merck Sharp & Dohme LLC

Publix Raspberry Coffee Cake (James Skinner) – Undeclared Walnuts (2025)

Undeclared Allergen

Undeclared allergen - walnuts. Maple Walnut Coffee Cake was incorrectly labeled as Raspberry Coffee Cake and walnuts were not declared on the label.

Class IIModerate

FDADec 10, 2025FL, IN• The James Skinner LLC

Ciclopirox Shampoo (Sun Pharma) – Impurity Specification Failure (2025)

Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint

Class II

FDADec 9, 2025Nationwide• SUN PHARMA /TARO

Grandma Belle's Tomato Soup (Lil Turtles) – Undeclared Milk (2025)

Undeclared Allergen

Undeclared allergen - milk

Class IIModerate

FDADec 4, 2025IL, IN, IA +11 more• Lil Turtles LLC

Wegmans Mixed Nuts (Mellace Brands) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella

Class IHigh

FDADec 2, 2025IN, NY, PA• Mellace Family Brands California Inc

Ritz Peanut Butter Crackers (Mondelez) – Mispackaging (2025)

Undeclared Allergen

Undeclared allergens (Peanut) due to mispackaging

Class IIModerate

FDANov 28, 2025AL, AR, GA +5 more• Mondelez Global Llc

Baclofen Tablets (Golden State) – Foreign Tablet Presence (2025)

Presence of Foreign Tablets/Capsules

Class II

FDANov 26, 2025Nationwide• Golden State Medical Supply Inc.

Morphine Sulfate Solution (Winder) – Mispack Label Issue (2025)

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

Class III

FDANov 26, 2025Nationwide• Winder Laboratories, LLC

Cisatracurium Besylate Injection (Somerset) – Subpotent Product (2025)

Subpotent product:out of specification assay results observed during long term stability testing.

Class III

FDANov 26, 2025Nationwide• SOMERSET THERAPEUTICS LLC

Cisatracurium Besylate Injection (Somerset) – Subpotent Product (2025)

Subpotent product:out of specification assay results observed during long term stability testing.

Class III

FDANov 26, 2025Nationwide• SOMERSET THERAPEUTICS LLC

Cisatracurium Besylate Injection (Somerset) – Subpotent Product (2025)

Subpotent product:out of specification assay results observed during long term stability testing.

Class III

FDANov 26, 2025Nationwide• SOMERSET THERAPEUTICS LLC

Fat Free Milk (Prairie Farms) – cleaning agent contamination (2025)

Product may contain food-grade cleaning agents

Class IIModerate

FDANov 25, 2025IL, IN, WI• Prairie Farms Dairy

Senna Leaf Herbal Tea (Celebration Herbals) – salmonella risk (2025)

Salmonella

possible salmonella

Class IIHigh

FDANov 25, 2025FL, IN, MA +5 more• CELEBRATION HERBALS US

Zen Cleanse Herbal Tea (Bell Industries) – salmonella risk (2025)

Salmonella

Potential Salmonella contamination

Class IIHigh

FDANov 24, 2025IN, MA, TX +1 more• Bell Industries LLC

Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Class II

FDANov 24, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Class II

FDANov 24, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Decaf Coffee Pods (Gimme Coffee) – undeclared caffeine (2025)

Undeclared Allergen

Undeclared caffeine

Class IIModerate

FDANov 24, 2025FL, IA, MD +7 more• Gimme Coffee, Inc.

Pecorino Romano Cheese (Wegmans) – listeria contamination (2025)

Listeria

Product may be contaminated with Listeria monocytogenes.

Class IVery High

FDANov 22, 2025CT, DE, MD +7 more• Wegmans Food Markets, Inc.

Cookie Butter Holiday Bark (Carousel Candies) – undeclared pecan (2025)

Undeclared Allergen

Undeclared pecan

Class ILow

FDANov 21, 2025Nationwide• Silvestri Sweets Inc dba Carousel Candies

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