All recalls8,436 total

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.

FDAHealth

Jul 9

SUBCO FOODS INC — Fox's u-bet Vanilla Flavored Syrup, 20oz, UPC 070216241016, 12 retail units per wholesale case

Customer complaint for bloated bottles. Testing and examination of these lots has revealed they did not meet specifications, including elevated pH and water activity levels. This may be indicative of microbiological activity, and concurrent risk of food-borne illness.

FDAFood

Jul 9

SUBCO FOODS INC — Fox's u-bet Sugar-Free Chocolate Flavored Syrup, 18oz, UPC 070216246004, 12 retail units per wholesale case

FDAFood

Jul 9

KALO Foods, LLC — All Natural KALO Chocolate Cake Gluten Free, UPC 8 53407 00418 4, Distributed by: Kalo Foods, LLC Stokesdale, NC 27357

Undeclared Soy. Carrot Cake slices were inadvertently placed into some Chocolate Cake slice containers. The Chocolate Cake ingredient statement does not list the allergen soy which is in the Carrot Cake.

FDAFood

Jul 9

SUN PHARMACEUTICAL INDUSTRIES INC — Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmaci

Failed Dissolution Specifications

FDAHealth

Jul 8

Stutz Packing Company — Shelled Walnuts 1lb package in plastic flexible packaging. 24 packages per case

Shelled walnuts tested positive for Listeria

FDAFood

Jul 8

Hikma Pharmaceuticals USA Inc. — Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)

FDAHealth

Jul 5

Lunds Mitchell Rd LLC — Lunds & Byerlys pesto salmon and lemon rice. UPC 18169-66396. Net Wt. 12 oz. (340.2g). Keep Refrigerated.

Peach tilapia and edamame rice steamer may be mis-labeled as pesto salmon and lemon rice: Undeclared Fish (Tilapia), and Soybeans

FDAFood

Jul 3

Costco Wholesale Corporation — The recalled product is mis-labeled as Ancient Grain + Vegetable Salad item #25247. Product is perishable, refrigerated, and packaged in clear dome clamshell plastic c

Undeclared Almond and Soy. The Grain + Celery Salad with Apple Cider Vinaigrette item #47492 was inadvertently mis-labeled as Ancient Grain + Vegetable Salad item #25247. Almond and Soy were not declared on the label of Ancient Grain + Vegetable Salad item #25247.

FDAFood

Jul 3

TAILSTORM HEALTH INC — Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Cha

Subpotent Drug: reduced efficacy for epinephrine

FDAHealth

Jul 2

Panaderia Guatemex — Panaderia Guatemex - Roscas packaged in plastic bag

Undeclared Allergen - Soy

FDAFood

Jul 2

Panaderia Guatemex — Panaderia Guatemex - Concha Mexicana packaged in plastic bag

Undeclared Allergen - Soy