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Showing 621–640 of 29086 results

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Iced Lemon Cookies (Carley's) - Misbranded Color (2025)

Product has a misbranded Yellow Color. Identified on label at Artificial Yellow Color , and it should be identified as FD&C Yellow #5

Class IIModerate

FDAJun 6, 2025AL, GA, IL +13 more• Carley's Inc.

Peak Cocktails Blood Orange Spritz (Peak Cocktails) – Exploding Cans (2025)

Overpressurization leading to exploding cans

Class IIModerate

FDAJun 3, 2025AL, AK, AZ +47 more• Peak Cocktails

Pizza Shoppe Pink Stuff Garlic Dressing (La Fontanella) – Potential Spoilage (2025)

Potential for product spoilage (increased level of lactic acid detected in retain samples).

Class IIModerate

FDAJun 2, 2025IN, IA, KS +1 more• La Fontanella Food Products LLC

Rocky Road Ice Cream (Unilever) – Mislabeled Allergens (2025)

Undeclared Allergen

Undeclared allergens and mislabeled product. Rocky Road Ice was packaged with Chocolate Truffle Ice Cream labeled tub and a Rocky Road Ice Cream lid. Tub said "may contain tree nuts" the lid said it did contain almonds.

Class IIModerate

FDAJun 2, 2025Nationwide• Unilever Manufacturing (US), Inc.

Lidocaine HCL Sterile Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Ketamine Hydrochloride 50mg Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Lidocaine HCL with Epinephrine Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Ketamine Hydrochloride Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Bupivacaine HCL Sterile Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Lidocaine HCl Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Eudos Bronquilan (Nature's Eudos) – Undeclared Colors (2025)

Undeclared Allergen

Undeclared colors (FD&C Yellow #5, FD&C Blue #1, and FD&C Red #40)

Class IIModerate

FDAJun 1, 2025NJ, NY• Nature's Eudos Distributors LLC

Icosapent Ethyl Capsules (Zydus) – Burnt Capsules (2025)

Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.

Class IIModerate

FDAMay 30, 2025IL, MS, PA• Zydus Pharmaceuticals (USA) Inc

Testo-200 Testosterone Injection (Advanced Pharma) – Unapproved Product (2025)

Marketed Without an Approved NDA/ANDA

Class IIModerate

FDAMay 30, 2025NJ, NY• Advanced Pharmaceutical Technology, Inc.

Firehook Artisan Sea Salt Crackers (Firehook) – Undeclared Sesame (2025)

Undeclared Allergen

Undeclared Sesame. The firm was notified by a retailer that product labeled as Sea Salt Bagel Crackers contained Everything Bagel Crackers. The Everything Bagel Crackers contains sesame which is not listed in the ingredient statement.

Class IIModerate

FDAMay 30, 2025CT, ME, MD +8 more• Firehook of Virginia

Gentamicin Pediatric Injection (Eugia) – Stability Failure (2025)

Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.

Class IIModerate

FDAMay 29, 2025Nationwide• Eugia US LLC

Casa Mamita Churro Bites (Camerican) – Undeclared Milk (2025)

Undeclared Allergen

Undeclared Allergen (Milk). Consumer found a breaded halloumi Cheese Stick in the bag of churro bites. The Halloumi Cheese contains milk which is not an allergen in the churros.

Class IIModerate

FDAMay 28, 2025AL, FL, GA +3 more• Camerican International Inc

Brimonidine/Timolol Ophthalmic Solution (Apotex) – Sterility Concerns (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 28, 2025Nationwide• Apotex Corp.

Ketorolac Ophthalmic Solution (Apotex) – Sterility Concerns (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 28, 2025Nationwide• Apotex Corp.

Dobutamine Injection (Pfizer) – Discolored Solution (2025)

Discoloration; discolored solution from cracked vials

Class IIModerate

FDAMay 28, 2025Nationwide• Pfizer Inc.

Azelastine HCl Ophthalmic Solution (Apotex) – Sterility Concerns (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 28, 2025Nationwide• Apotex Corp.

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