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Moringa Rice Mix (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Horsegram Soup (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Curry Leaf Rice Mix (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Rice Papad (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Vallarai Rice Mix (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Veggie Snack Bistro Box (Fresh & Ready Foods) – Listeria risk (2025)

Listeria

Listeria Monocytogenes detected on food contact surfaces in Ready To Eat sandwich manufacturer facility.

Class IIModerate

FDAMay 10, 2025AZ, CA, NV +1 more• Fresh & Ready Foods LLC

Phentermine Hydrochloride Capsules (KVK Tech) – Manufacturing Deviation (2025)

cGMP deviations

Class IIModerate

FDAMay 9, 2025Nationwide• KVK Tech, Inc.

Chlorthalidone Tablets (AvKARE) – Dissolution Specification Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAMay 9, 2025Nationwide• AvKARE

Indomethacin Extended-Release Capsules (KVK Tech) – Manufacturing Deviation (2025)

cGMP deviations

Class IIModerate

FDAMay 9, 2025Nationwide• KVK Tech, Inc.

Celecoxib Capsules (Alembic) – Foreign Tablet Contamination (2025)

Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

Class IIModerate

FDAMay 9, 2025Nationwide• Alembic Pharmaceuticals Limited

Sabudana Khichadi (Shastha Foods) – Undeclared Allergens (2025)

Undeclared Allergen

Undeclared allergens (milk and/or peanuts).

Class IIModerate

FDAMay 8, 2025CA, UT, WA• Bondsforever, Inc dba Shastha Foods

Pohe (Shastha Foods) – Undeclared Allergens (2025)

Undeclared Allergen

Undeclared allergens (milk and/or peanuts).

Class IIModerate

FDAMay 8, 2025CA, UT, WA• Bondsforever, Inc dba Shastha Foods

Bromfenac Ophthalmic Solution (Alembic) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAMay 7, 2025Nationwide• Alembic Pharmaceuticals Limited

Apple & PB Snack Cup (GBC Food Services) – Plastic Contamination (2025)

Foreign Material (plastic)

Class IIModerate

FDAMay 6, 2025GA, IN, MI +1 more• GBC Food Services, LLC

Celery & PB Snack Cup (GBC Food Services) – Plastic Contamination (2025)

Foreign Material (plastic)

Class IIModerate

FDAMay 6, 2025GA, IN, MI +1 more• GBC Food Services, LLC

Testosterone Cypionate Injection (Empower Pharmacy) – Sterility Risk (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2025Nationwide• Empower Clinic Services, LLC dba Empower Pharmacy

Testosterone Pellet 100mg (BSO) – Particulate Matter Risk (2025)

Presence of Particulate Matter: Glass particles were found in pellet vials.

Class IIModerate

FDAApr 28, 2025Nationwide• BSO LLC

Testosterone Pellet 200mg (BSO) – Particulate Matter Risk (2025)

Presence of Particulate Matter: Glass particles were found in pellet vials.

Class IIModerate

FDAApr 28, 2025Nationwide• BSO LLC

Testosterone Pellet 200 mg (BSO LLC) – Glass Particle Contamination (2025)

Presence of Particulate Matter: Glass particles were found in pellet vials.

Class IIModerate

FDAApr 28, 2025Nationwide• BSO LLC

Temper Tamer Oral Spray (Siddha Flower Essences) – Manufacturing Deviation (2025)

CGMP Deviations

Class IIModerate

FDAApr 28, 2025Nationwide• Siddha Flower Essences, LLC.

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