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Showing 861–880 of 29086 results

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Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

Class IIModerate

FDAMar 26, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Desert Farms Jalapeno Mustard – process violation (2025)

The product is in violation for not having an approved filed process and for not having monitoring records.

Class IIModerate

FDAMar 26, 2025Nationwide• The Truck Farm, LLC

Buffalo Wing Sauce (Lillie's Q) – hidden milk allergen (2025)

Undeclared Allergen

Undeclared allergen (milk not listed as sub ingredient of butter). Milk also not listed in 'Contains' statement.

Class IIModerate

FDAMar 25, 2025CA, CO, CT +11 more• OLD WORLD SPICES & SEASONING, INC

Kashk Whey (Nader Trading) – unlisted milk allergen (2025)

Undeclared Allergen

Finished product label fails to include Milk in ingredient listing. (Undeclared Allergen)

Class IIModerate

FDAMar 25, 2025CA, MD, VA• Nader Trading, Inc.

Falafel King Mediterranean Meal – unlisted sesame (2025)

Label declares tahini paste but does not declare sesame.

Class IIModerate

FDAMar 25, 2025CO, IN• Falafel King Enterprises, Inc.

MULTI-V Multivitamin (MTN OPS) – undeclared soy (2025)

Undeclared soy flour

Class IIModerate

FDAMar 25, 2025Nationwide• MTN OPS, LLC

Clindamycin HCl Capsules (RemedyRepack) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 24, 2025PA• RemedyRepack Inc.

Voriconazole Tablets (Amerisource) – Supplier Notification (2025)

cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.

Class IIModerate

FDAMar 24, 2025Nationwide• Amerisource Health Services LLC

Gianduja Noir Chocolate (Cacao Barry) – undeclared milk (2025)

Undeclared Milk

Undeclared milk

Class IIModerate

FDAMar 22, 2025CA, FL, GA +5 more• Barry Callebaut USA LLC

Methocarbamol Injection (Somerset) – Sterility Risk (2025)

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

Venlafaxine Tablets (Zydus) – Foreign Material Risk (2025)

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

Class IIModerate

FDAMar 21, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

Fresh Flax Oil (Bioriginal) – undeclared soy (2025)

Undeclared Allergen

Undeclared allergens: Soy lecithin

Class IIModerate

FDAMar 21, 2025PR• Bioriginal Food & Science Corporation

Brioche Bread and Buns (Baking Group) – Undeclared Allergens (2025)

Undeclared Allergen

Undeclared allergens (soy, milk) and Yellow #5

Class IIModerate

FDAMar 19, 2025TX• Harvey Investments LLC / The Baking Group

Favorite Day New York-Style Cheesecake (Dessert Holdings) – Undeclared Pecan (2025)

Undeclared Allergen

Undeclared Pecan. The firm was notified by their customer that when they were placing the product on the shelves, they noticed the wrong product was in the container.

Class IIModerate

FDAMar 19, 2025CA, FL, IA +2 more• Dessert Holdings Llc

Turkey BLT on Sourdough (Hearn Kirkwood) – Incorrect Sandwich (2025)

Undeclared Allergen

Turkey BLT on Sourdough Sandwiches being recalled due to the product having the incorrect sandwich (Peanut Butter & Jelly) in the clamshell container. This incorrect product in the container resulted in an undeclared allergen on the product label (peanuts).

Class IIModerate

FDAMar 19, 2025NY• The Coastal Companies DBA Hearn Kirkwood

Arepas de Chocolo (Delicias de la Abuela) – Undeclared Soy (2025)

Undeclared Allergen

Undeclared allergen: Soy lecithin, less than 2%

Class IIModerate

FDAMar 18, 2025FL• DELICIAS DE LA ABUELA INC

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