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All recalls7,967 total

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My Chai Inc — MySyrup Sugar Free Raspberry Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural flavor, vanilla extrac

Acidified product is recalled due to lack production record.

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My Chai Inc — MyChai Chai Tea Concentrate Double. Product is packaged in the same square 0.5 gallon HDPE plastic bottles and have volumes of 68 fl oz. Ingredients: Water, Sugar, Organic Black Tea, Or

Acidified Chai Tea product is recalled due to lack production record.

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My Chai Inc — MySyrup Sugar Free Coconut Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural flavor, potassium sorbate

Acidified product is recalled due to lack production record.

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My Chai Inc — MySyrup Sugar Free Hazelnut Syrup. Product is packaged in the same square 0.5gallon HDPE plastic bottles and the volume is 68 fl oz. Ingredients: Water, natural and artificial flavor, p

Acidified product is recalled due to lack production record.

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Lupin Pharmaceuticals Inc. — Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limi

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

I
Intuitive Surgical, Inc. — da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40

Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure

M
Milo's Poultry Farms, LLC — Grade A Brown Chicken Eggs, in shell, Bulk 15 dozen. For Foodservice. Keep Refrigerated. Sold with the following brands: 1. Milo's Poultry Farms, N 3873 Valley Road, B

Eggs have the potential to be contaminated with Salmonella.

E
Elevate Oral Care — Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite

LABELING: LABEL MIX-UP.

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Mothers' Milk Bank of Alabama — MMBAL pasteurized donor human milk (PDHM), 100 mL (3.38 fl. oz.), packaged in a BPA-free plastic bottle

Potential physical contaminant

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Nuts.com — Nuts.com Paprika 25 lb, packaged in a clear plastic bag. 1 bag per cardboard box.

Possible Salmonella contamination

G
Gutierrez Distributors, LLC — El Servidor Corp Ground Cinnamon Net Wt. 1.5 oz. UPC: 745245113244. Packaged in clear plastic bag. 12 bags per case. Gutierrez Distributor Canela Molida Ground Cinnamon

Elevated lead levels in cinnamon

R
Refresco Beverages US Inc — Great Value; 8oz Apple Juice in 6 pack; 100% Juice; packaged in 8 oz. PET plastic bottles; UPC 0-78742-29655-5

Product contains inorganic arsenic above action level set in industry guidance (13.2ppb)

F
Fagron Compounding Services — Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.

Lack of Assurance of Sterility

B
Biocompatibles UK, Ltd. — Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, D

Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).

N
Now Foods — NOW Real Foods Whole & Unsalted Raw Brazil Nuts 12oz. bag UPC 733739070128

High mold, yeast, and total viable count

A
AUTHENTIK FUDGE — Montreal Fudge brand Chocolate Fudge with Nuts; 5.6oz

Product may be contaminated with mold.

F
Flagstone Foods, LLC — 6.5oz Emerald Kettle Glazed Walnut, UPC: 0 10300 80894 7

undeclared peanuts, almonds and pecans

F
FDC Limited — Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Auranga

Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

P
Prime Food Processing Corp. — Prime Food brand Steam Bun with Egg Custard & Coconut Added; 10pcs/pack; NET WT. 20 oz (1lb.4 oz) 568g; KEEP FROZEN; INGREDIENTS: Dough: Bleached Wheat Flour, Water, Suga

Products may contain undeclared sesame

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Prime Food Processing Corp. — Prime Food brand Steam Bun with Egg Custard Added; 10pcs/pack; NET WT. 20 oz (1lb.4 oz) 568g; KEEP FROZEN; INGREDIENTS: Dough: Bleached Wheat Flour, Water, Sugar, Salad O

Products may contain undeclared sesame

D
Direct Rx — Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC,

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.

K
Kester Foods LLC — Yummy Monkey Organics Butter & Yeast Popcorn, Made With Purified Ghee & Nutritional Yeast. UPC 9 96692 66641 2, packaged in a Clear Polyethylene Gusseted Re-closable Bag measured 9

Label declares butter and ghee but does not declare milk.

K
Kester Foods LLC — Yummy Monkey Organics Real Movie Theater Popcorn, Made With Purified Ghee & Himalayan Sea Salt. UPC 9 96692 66654 2, packaged in a Clear Polyethylene Gusseted Re-closable Bag measu

Label declares butter and ghee but does not declare milk.

T
Teva Pharmaceuticals USA, Inc — Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-29

Superpotent Drug

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Preferred Pharmaceuticals, Inc. — Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.

Failed Impurities/Degradation Specifications - at 18-month Stability testing

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Meijer Inc — MEIJER DUNKING COOKIES CHOCOLATE CHIP, 10oz in clear plastic container. UPC 7-13733-71297-2

undeclared milk

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Taro Pharmaceuticals U.S.A., Inc. — Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

D
Dr. Reddy's Laboratories, Inc. — IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottl

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

D
Dr. Reddy's Laboratories, Inc. — IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bott

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

D
Dr. Reddy's Laboratories, Inc. — IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottl

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

P
PBM Nutritionals, LLC — CVS Health brand and HEB Baby brand Premium Infant Formula with Iron Milk-Based Powder; packaged in 964g composite cans; 4 cans per case; UPC 50428318034 and 41220164578

Product contains levels of Vitamin D above the maximum level permitted.

Z
Zeco LLC — Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401

CGMP Deviations: sterile water not used for production

Z
Zeco LLC — HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon dru

CGMP Deviations: sterile water not used for production

R
Reser's Fine Foods, Inc. — UPC 71117 14743, Reser s Rotisserie Chicken Salad Base 2lb. (32oz), refrigerated, packaged in an opaque plastic tub with a white printed plastic lid. There are 6 tubs per ca

Foreign material.

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Reser's Fine Foods, Inc. — UPC 71117 19063, Reser's American Classics Garden Pasta Salad 16oz, refrigerated, packaged in an opaque printed plastic tub with a plastic red printed lid. There are 6 tubs

Foreign material.

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Reser's Fine Foods, Inc. — UPC 78742 12653, Walmart Original Freshness Guaranteed Macaroni Salad 16oz, refrigerated, packaged in a clear plastic tub with printed labels on top, bottom and side. There

Foreign material.

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PARADISE DISTRIBUTORS, LLC — Yummy brand Swirly Ices Fruity Melon flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC:734690007536 Also packaged in 30 count packs

Undeclared milk.

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PARADISE DISTRIBUTORS, LLC — Yummy brand Swirly Ices Berry Blast flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC: 734690007550 Also packaged in 30 count packs

Undeclared milk.

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PARADISE DISTRIBUTORS, LLC — Yummy brand Swirly Ices Tropical Tornado flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC:734690007567. Also packaged in 30 count packs

Undeclared milk.

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Reser's Fine Foods, Inc. — UPC 71117 19084, Reser's American Classics Spicy Pickle Potato Salad 16oz, refrigerated, packaged in an opaque printed plastic tub with a plastic red printed lid. There are

Foreign material.

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PARADISE DISTRIBUTORS, LLC — Yummy brand Swirly Ices Churning Cherry flavor Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC:734690007543 Also packaged in 30 count packs

Undeclared milk.

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Reser's Fine Foods, Inc. — UPC 78742 02670, Walmart Original Freshness Guaranteed Macaroni Salad 3lb. (48oz), refrigerated, packaged in an opaque printed plastic tub with a plastic white printed lid.

Foreign material.

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Reser's Fine Foods, Inc. — UPC 95515 04502, Amazon Fresh Fresh Classic Macaroni Salad 16oz, refrigerated, packaged in a clear plastic tub with printed labels on top, bottom and side. There are 12 tubs

Foreign material.

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PARADISE DISTRIBUTORS, LLC — Yummy brand Swirly Ices Assorted Flavors Net Wt. 2.3 ounces (65g)x 8 popsicles, Total Net Wt. 18.34 ounces (520g) UPC: 734690007574. Contains Fruity Melon, Churning Cherry

Undeclared milk.

E
EMPOWER CLINIC SERVICES LLC — Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houst

Lack of Assurance of Sterility

J
J F C International Inc — J-Basket Brand, Napa Kimchi, Net Wt. 14.1oz. plastic jar container (12 jars per case).

High levels of Yeast growth and film on top of jarred Kimchi product.

T
Thal Golden Spices Inc. — Bikano Moong Dal Crunchy Green Gram Net Weight 12.35oz (350g) Product of India Manufactured by: Bikanervala Foods Pvt. Ltd. B1-Plot No. 42 (Khasra No. 661-662), Ecotech II,

Potential Salmonella contamination.

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North Fish USA, Inc. — Cold Smoked Capelin, 9-ounce packages, plastic trays, 34 packages per case (Best By Date:07.13.2024), 18 packages per case (Best Buy Date: 01.05.2025), UPC code4811527003360, Ke

Clostridium botulinum (uneviscerated fish)

B
Baxter Healthcare Corporation — Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

A
Amneal Pharmaceuticals, LLC — Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

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