Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

Hawthorne, NY, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · device

CooperVision, Inc. — Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day

A small number of lenses within the affected lot are of the incorrect power.

West Henrietta, NY, US · Updated 9/18/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · drug

American Regent, Inc. — Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY

Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.

Shirley, NY, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · food

Wonton Specialists — Wonton Specialist Inc. Wonton Noodle, 12 oz - packaged in foam tray overwrapped with clear plastic and 5lb - packaged in clear plastic bags

Undeclared FD&C Red No. 40

Brooklyn, NY, US · Updated 9/9/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · food

Prince Bakery Inc — Prince ITALIAN BREAD; Sesame; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR, NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVI

Sesame is not declared in the ingredient statement but is declared in the statement of identity.

Bronx, NY, US · Updated 9/9/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · food

Prince Bakery Inc — Prince PAN DE MANTECA; SPANISH STYLE; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR, NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, R

Milk is not declared in the Contains statement.

Bronx, NY, US · Updated 9/9/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · food

THE HAMPTON GROCER — THE HAMPTON GROCER brand; Lacnola; SMALL BATCH LACTATION GRANOLA, 8oz, stand up pouches; NUTRIENT DENSE INGREDIENTS + MORINGA; SUPPORTS + PROMOTES HEALTHY LACTATION; INGREDIENTS Or

Product may be contaminated with Salmonella.

Montauk, NY, US · Updated 9/9/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · food

Prince Bakery Inc — Prince Sesame FRENCH BREAD; LONG FRENCH; Net Wt. 10 oz (284g); INGREDIENTS: ENRICHED BLEACHED FLOUR, (WHEAT FLOUR, MALT BARLEY FLOUR< NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE,

Sesame is not declared in the ingredient statement but is declared in the statement of identity.

Bronx, NY, US · Updated 9/9/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · food

Wonton Specialists — Wonton Specialist Inc. Pan Fried Noodle, 16 oz and 5lb packaged in clear plastic bags

Undeclared FD&C Red No. 40

Brooklyn, NY, US · Updated 9/9/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · food

Wonton Specialists — Wonton Specialist Inc. Wonton Skin, 16 oz - packaged in foam tray overwrapped with clear plastic

Undeclared FD&C Red No. 40

Brooklyn, NY, US · Updated 9/9/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · food

Wonton Specialists — Wonton Specialist Inc. Lo Mein Noodle, 16 oz, packaged in clear plastic bags

Undeclared FD&C Red No. 40

Brooklyn, NY, US · Updated 9/9/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · food

Wonton Specialists — Wonton Specialist Inc. Dumpling Skin, 16 oz - packaged in foam tray overwrapped with clear plastic

Undeclared FD&C Red No. 40

Brooklyn, NY, US · Updated 9/9/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · food

Wonton Specialists — Wonton Specialist Inc. Cooked Noodle, 16 oz and 5 lb - packaged in clear plastic bags

Undeclared FD&C Red No. 40

Brooklyn, NY, US · Updated 9/9/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · food

Prince Bakery Inc — Prince ITALIAN BREAD; Sesame; ITALIAN & FRENCH BREAD, LARGE; NET WEIGHT 12 OZ. (340g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR< NIACIN, FERROUS SULFATE

Sesame is not declared in the ingredient statement but is declared in the statement of identity.

Bronx, NY, US · Updated 9/9/2026, 12:00:00 AM UTC

Source: FDA — food enforcement reference

Reference notice · drug

American Regent, Inc. — ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AM

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

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