FDA Recalls in 2025

Eskay Brands Mint flavored tablets. 40mg 7OH/550mg Tablet- Eskay Brands-Mint, Chewable tablet, no shelf-life. Dosage: 2 doses per tablet. 10,000 or less per bulk bag. Bulk package and is not sold directly to consumer.

Undeclared Yellow #5

Ultra Whey Protein Powder; 1.4 lbs and 1.4 lbs. Chocolate flavor UPC: NA

undeclared allergen ingredient Milk.

G&L Food Dried Bean Curd Net WT 17.6 OZ (500G) INGREDIENTS: Soybean, Water, Magnesium Chloride as Preservative CONTAINS: Soybean 121C was sterilized at high temperature PRODUCT OF CHINA U.S.A. Distributed By: G&L PRODUCE INC 1140 REVERE AVE SAN FRANCISCO CA 94124 UPC: 6976325560236

Undeclared allergen (wheat).

Lifted Made Mint flavored tablets 20mg 7OH/550mg Tablet- Lifted Made-Mint, Chewable tablet, no shelf-life. Dosage: 2 doses per tablet. Shipping or unit package: 10,000 or less per bulk bag. Bulk package and is not sold directly to consumer.

Undeclared Yellow #5

Organic BABY bedtime drops; sleep + immunity blend; Promotes restful sleep with natural herbs & supports immunity with elderberry & vitamin C; LIQUID DIETARY SUPPLEMENT; AGE 4 MONTHS+, NET WT. 2 OZ (60 ML)

Potential yeast contamination.

Scott & Jon s Honey Sesame Salmon Rice Bowl

contains undeclared wheat

Meal In A Glass protein powder. 1.05 lbs and 4.5 lbs container. UPC: NA Vanilla, Chocolate and Strawberry flavor.

undeclared allergen ingredient Milk.

Harris Teeter CINNAMON TEXAS TOAST, NET WT 5.0oz (0.31g), INGREDIENTS BREAD*** CONTAINS WHEAT, UPC 0 72036 95734 4, Harris Teeter Raleigh, NC

Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in the contain statement.

Gluta Plus (Glutathione) 60 capsules/container. UPC: NA

undeclared allergen ingredient Milk.

Toto S'Mores Ooey Gooey Cookie; Gluten Free & Dairy Free; Net Wt. 2.25 OZ Rear panel: Packed with superfoods; Gluten, Dairy & Soy Free UPC: 860010409398

Product label contains conflicting statements about inclusion and being free of Soy ingredient.

Lifted Made-Lemon, Chewable tablet. 20mg 7OH/550mg Tablet-no shelf-life. Dosage: 2 doses per tablet. Route of administration: oral. Shipping or unit package 10,000 or less per bulk bag. Bulk package and is not sold directly to consumer.

Undeclared Yellow #5

El Rojo Pasta De Harina, Wheat Pellets. Net Wt 8 oz. (225g) UPC 0 35579-80871 6. Packaged and distributed by: El Rojo Wholesale, Maple Grove, MN 55469.

Product is missing the ingredient list (which lead to missing wheat and Yellow No. 6), and a nutritional panel.

Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)

Failed Dissolution Specifications.

Goot Essa, Der Mutterschaf Cheese, Sheep Tomme Style. 4 and 8 OZ. ( Pasteurized Sheep Milk, Salt, Vegetable Enzymes, Cheese Cultures ).

The firm had a positive Listeria Monocytogenes on a sample from this batch of product made.

Vanilla Cookies with Raspberry Peach Jam

Undeclared Red 3 and Blue 1

Whole Foods Market Blueberry Almond Granola, PLU 86032, packaged in a clear plastic container.

Product was incorrectly labeled, resulting in undeclared wheat, sesame, and cashew.

Toasted Cherry Biscotti

Contains undeclared Red 40

Frozen Raw Easy Peel shrimp, IQF, 2-lb bag, 10 bags/case; Generic Brown cardboard box UPC: 021130123223

Product which was on FDA hold for high levels of Nitrofuran was inadvertently distributed.

Italian Sesame Cookies

Undeclared Sesame, Undeclared Yellow 5, Red 40, Yellow 6

190 cs Cucumber Select 15ct

Product is contaminated with Salmonella

98 cs Cucumber - Super 6 Ct

Product is contaminated with Salmonella

15 lbs. Cucumbers Diced 1/4"

Product is contaminated with Salmonella

Shrimp Cocktail Bowl; 7oz clear plastic retail packaging. UPC: 011110622952 Shrimp Cocktail Bowl; 17oz clear plastic retail packaging. UPC: 011110624840

Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)

Vanilla with Apricot Jam Cookies

Undeclared Red 40 and Yellow 6

Lipton Green Tea Citrus. 16.9 ounce PET Bottle. sold as 12pk. Outer case label reads as , "* Lipton Green Tea Citrus (25g sugar)" Individual bottle label reads as " Lipton Diet Green Tea Mixed Berry (0g sugar)*). Shelf stable.

Undeclared sugar in finished product-primary package does not reflect the product inside bottle.

Vanilla Chocolate Dipped Cookies

Undeclared Red 40

vitamins B12 dietary supplement Raspberry Flavored sold under the following brand names: 1. Black Girl Vitamins 60 gummies UPC 8 60008 57505 0 Manufactured for: Black Girl Vitamins 601 W Harrison St., Chicago, IL 60607. 2. Rise-N-Shine 17 Woodport Road, Sparta, NJ 07871 UPC 8 99130 01189 1

Undeclared Peanuts. The firm was notified by their supplier, that the product may contain undeclared peanuts.

NAFCO, WHITING FILLET SKIN-ON BONELESS IQF, 2 lb., Cases are corrugate. The product is individually frozen and packed in food contact retail bag. 15 bags per case. Keep Frozen

Recall initiated due to the wrong best by date (1-11-2025) being printed on the retail bag which would imply that these are expired but in truth they are good until 1-11-2027.

Toasted Almond & Cherry Biscotti

Undeclared Red 40

5 lbs. Cucumber Diced 1/2"

Product is contaminated with Salmonella

16/25 Frozen Cooked Tail-On Farm Raised Shrimp; 12oz clear plastic retail bag. UPC: 011110649812 51/60 Frozen Cooked Tail-On Farm Raised Shrimp; 32oz clear plastic retail bag. UPC: 011110967015

Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)

10lbs. Cucumbers Sliced 1/4", 5 lbs. Cucumber Sliced 1/4"

Product is contaminated with Salmonella

Orwashers brand Soho Sourdough XL Batard; contains: wheat; 6-46.4oz PIECES PER CASE

Mislabeled: Product may contain undeclared sesame seeds

Italian Mixed Vanilla Cookies

Undeclared Almonds, Sesame, Red 40, Red 3, and Blue 1

Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52

CGMP Deviations: Market complaints received for gritty texture (grainy)

edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14

Cross Contamination with Other Products.

Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14

Cross Contamination with Other Products.

ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01

Failed Impurities/Degradation Specifications:

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01

Failed Impurities/Degradation Specifications:

mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01

Failed Impurities/Degradation Specifications:

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01

Failed Impurities/Degradation Specifications:

Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave, Ste 200, Sacramento, CA 95825.

Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.