FDA Recalls in 2025

Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17

CGMP Deviations

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1

CGMP Deviations

Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01

Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis

Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8

CGMP Deviations

Whatcom Blue Sliced cheese; Sliced and packaged in deli plastic wrap with Whole Foods Scale labels.

Twin Sisters Creamery's recall of cheese products due to WSDA testing that identified potential STEC and E. coli O103 contamination. Whole Foods Market received affected products through distributor Peterson Company and sold them by weight with store-generated labels.

Nat's Nuts Cinnamon Whiskey Pecans, 4 oz.

Contains undeclared cashews

Face Rock Creamery Vampire Slayer Garlic Cheddar, net wt. 6oz. Ready to Eat, Refrigerated/ Perishable. Product is packaged in sealed in bag and shrink dipped. UPC 8 51222 00547 8. Face Rock Creamery, 680 2nd St. SE Bandon, OR 97411.

FDA environmental sample identified the presence of Listeria monocytogenes in the processing area where cheese was packaged.

Jeni's Passion Fruit Dreamsicle Ice Cream Bars, 3 FL OZ (89 ML)/9 FL OZ (266 ML), packaged 3 bars per retail carton with Item UPC: 850060644122, packed 8 retail cartons per case with Case UPC: 10850060644129

Undeclared allergens - wheat and soy

Member's Mark Super Greens Dietary Supplement; 48 servings; Net Weight 18.28 oz (518.4g) UPC: 193968490775

Potential contamination of Salmonella Richmond

Whatcom Farmhouse- Sliced and packaged in deli plastic wrap with Whole Foods Scale labels.

Twin Sisters Creamery's recall of cheese products due to WSDA testing that identified potential STEC and E. coli O103 contamination. Whole Foods Market received affected products through distributor Peterson Company and sold them by weight with store-generated labels.

DEVI brand Cinnamon Powder (Dalchini Powder), net wt.: 3.5 oz (100 g), packaged in flexible plastic bag. UPC 6 09595 11904 5. Imported and Distributed by Homeneeds Inc. Bellevue, WA 98007; Product of India

Elevated levels of lead. FDA ground cinnamon sample was found to contain 2.92 mg/kg.

VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.

Invalid calibration with low calibrator S1 while using the product.

The recalling firm issued letters to the end users dated April 2018, via FedEx 2 Day Express explaining the issue, potential risk to health, and requested the impacted lots be destroyed. For further questions, please call (314) 731-8805.

Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90

Failed Dissolution Specifications

DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq

UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq

Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.

CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.

McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05

Subpotent Drug

4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Twin Sisters Creamery Whatcom Blue cheese, 2.5lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, salt, enzymes, penicillium roqueforti. Made in Ferndale, WA. www.twinsisterscreamery.com.

Raw milk Whatcom Blue cheese is recalled due to E. coli O103:H2.

Item# 29608 Farmhouse White, Twin Sisters Creamery brand, product is packed in Cryovac and each package weighs 5oz-6oz. This cheese is made from raw milk. Ingredients: cultured raw cow's milk, salt, enzymes, penicillium roqueforti. Made by Twin Sisters Creamery in Ferndale, WA. Distributed by Peterson Company of Auburn, WA.

Item #29608 Farmhouse White is recalled due to E. coli O103:H2.

Dry Ghoinnya Fish

Un-eviscerated fish may be contaminated with Clostridia botulinum.

Bulk and Organic Organic Moringa Powder, 44.1lbs bag

Possible Salmonella Richmond

Publix Rich & Creamy Vanilla Ice Cream

Undeclared Eggs

Twin Sisters Creamery Mustard Seed cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: Cultured raw cow's milk, salt, whole yellow mustard seeds and enzymes. Made in Ferndale, WA. www.twinsisterscreamery.com.

Raw milk Mustard Seed cheese is recalled due to E. coli O103:H2 and E. coli O74:H25.

Twin Sisters Creamery Farmhouse Cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, salt, and enzymes. Made in Ferndale, WA. www.twinsisterscreamery.com.

Raw milk Farmhouse cheeses are recalled due to E. coli O103:H2 and E. coli O74:H25.

Cinnamon Powder; 8oz clear plastic container. Distributed by Haitai Inc. UPC: 0 20914 81415 9

Elevated levels of lead in Cinnamon powder.

Rockport Lobser Bisque; packed in 2x8lb pouches and in 4x4b pouches

Products contain undeclared shrimp (crustacean shellfish)

Item# 28855 Whatcom Blue, Twin Sisters Creamery brand, product is packed in Cryovac and each package weighs 5oz-6oz. There are 16 pieces per case. This cheese is made from raw milk. Ingredients: cultured raw cow's milk, salt, enzymes, penicillium roqueforti. Made by Twin Sisters Creamery in Ferndale, WA. Distributed by Peterson Company of Auburn, WA.

Item #28855 Whatcom Blue is recalled due to E. coli O103:H2

Twin Sisters Creamery Peppercorn cheese, 3lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, whole peppercorns, salt, enzymes. Made in Ferndale, WA. www.twinsisterscreamery.com.

Raw milk Peppercorn cheese is recalled due to E.coli O26:H11

Item IL1014A, PIGGY Lotte Crispy Crunch Ice Cream Cone, Strawberry flavor, Keep Frozen, (4/5/160ML), UPC 8801118255045. Product of Korea. The label of recalled product declared: Ingredients: Cone snack, Strawberry syrup, Biscuit, Chocolate spray, Topping Chocolate, Ice cream mix (Sugar, Mixed milk powder, Processed Butter, Processed oligosaccharide, Mixed formulation, Natural vanilla flavor, synthetic vanilla flavor, water) CONTAIN: Milk.

Undeclared peanut.

Carton Label: PACIFIC FRESH VEGETABLES PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 Carton Sticker Label: Conv Italian Parsley 60 Ct Ctn Pacific Product of USA Distributed By: Dynasty Farms Salinas, CA 93905 UPC 40695 80125 Twist Tie (for bunches) Label: FLAT PARSLEY PLU #4901 PROUDCT OF USA UPC 40695 80125

Potential contamination with Salmonella.