FDA Recalls in 2025

Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Limited Athlone, Ireland, NDC 0006-3066-03

Presence of particulate matter: potential presence of metal particulates in the product.

Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02.

Presence of particulate matter: potential presence of metal particulates in the product.

Locatelli Pecorino Romano Cheese Grated (Wegmans #270010) Packaged and sold by the pound Packaged in cylindrical clear plastic tubs with lid UPC: 2-77580-XXXXX-7, where X is the unit price of the container

Product may be contaminated with Listeria monocytogenes.

1) Wegmans Deluxe Mixed Nuts, Unsalted, Net Wt. 34 oz. (964g), packaged in a plastic tub with UPC 077890421314, packed 6 tubs per case 2) Wegmans Deluxe Mixed Nuts, Unsalted, Net Wt. 11.5 oz. (326g), packaged in a plastic bag with UPC 077890421352, packed 12 bags per case

Potential contamination with Salmonella

Publix Raspberry Coffee Cake, Net Wt. 15 oz. (425g), packaged in an aluminum foil tray and clear plastic clamshell lid with wraparound label, UPC 0-41415-54691-2, Distributed By Publix Supermarkets, Inc. Lakeland, FL 33802, packed 12 per case Case label reads, in part: Maple Walnut Coffee Cake, 12 units/14 oz. each, Net Wt. 10.5 LB (4.6 kg), UPC 100 41415 54591 2

Undeclared allergen - walnuts. Maple Walnut Coffee Cake was incorrectly labeled as Raspberry Coffee Cake and walnuts were not declared on the label.

Organic Ginger Root Herbal Supplement, Natural anti-inflammatory properties, supports gut, increases circulation, 50 capsules/560 mg, packaged in a plastic bag

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Chaga Mushroom Herbal Supplement, 1:5 Alcohol Double Extract, Supports a healthy immune system with anti-cancer properties; packaged in a 2 oz. glass dropper bottle, UPC 284588087831

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Ritz Peanut Butter Cracker Sandwiches, Net Wt. 27.6 oz.- 20 Count (20 x 1.38-oz. 6-pack carton)

Undeclared allergens (Peanut) due to mispackaging

Product: Zimi Kunefe Ready to eat (Frozen) Package Size and quantity per case: 380 g paper carton/tray - 9/case UPC: 5201592015822

partially hydrogenated oils (PHOs) in foods exported to the US

Product: Zimi Puff Pastry French Style (frozen) Package Size and quantity per case: 700 g paper carton - 12/case UPC: 5201592020017. Frozen.

partially hydrogenated oils (PHOs) in foods exported to the US

First & Last Tavern Marinara Sauce (tomato & basil) 26 FL OZ (1 lb, 10 oz) 737g

May be contaminated with Clostridium botulinum

Sinus Cap Herbal Supplement, Herbs containing antibiotic, drying, expectorant, and emollient properties, Fenugreek, Thyme, Oregon Grape Root, & Bentonite Clay, 50 capsules/510 mg; packaged in a plastic bag

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Anti-virus Herbal Supplement, 1:5 Alcohol Tincture, Helps to stop viral replication, expectorant properties, Contains: Forsethia blossoms, Sumac berries, Pine needles; packaged in a 2 oz. glass dropper bottle, UPC 283162814429

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Choceur Pecan Cranberry & Cinnamon Holiday Bark. Standup Pouch Bag. 5 oz. (142g). UPC: 4069365095829. Wholesale unit is split case, with 9 of each item per case.

Undeclared wheat

Zen Cleanse Blend herbal tea; .95 oz (27g) pouch; 18 pouches/box UPC: 819005011504

Potential Salmonella contamination

Ear Drops Herbal Supplement, Mullein flower alcohol tincture 1:5, Pain relieving and antibiotic properties, packaged in a 0.5 oz. plastic dropper bottle

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Grandma Belle's Tomato Basil Soup, Net Wt. 17 oz. (482g), packaged in a glass jar, UPC 810084612293, Made By: Lil' Turtles 504 North Ray Street, Baltic, Ohio 43804, packed 12 jars per case

Undeclared allergen - milk

First & Last Tavern Puttanesca Sauce (olives, capers, hot peppers) 26 FL OZ (1 lb, 10 oz) 737g

May be contaminated with Clostridium botulinum

Pain Away Herbal Supplement, Analgesic & anti-inflammatory properties, Wood Betony & White Willow in vegetable glycerin, packaged in a 4.5 oz. glass bottle or 9 oz. glass bottle, UPC 231946534537

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Boswellia Herbal Supplement, 1:5 Alcohol Double Extract, Extracted from Frankincense with powerful anti-inflammatory properties, useful for pain & inflammation; packaged in a 2 oz. glass dropper bottle, UPC 284260392420

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Choceur Cookie Butter Holiday Bark. Standup Pouch Bag. 5 oz. (142g). UPC: 4069365095690. Wholesale unit is split case, with 9 of each item per case.

Undeclared pecan

First & Last Tavern Traditional Pasta Sauce (meat flavored) 26 FL OZ (1 lb., 10 oz) 737g

May be contaminated with Clostridium botulinum

Baby Soothe Herbal Supplement, Promotes rest, helps ease colic, upset stomach, and teething discomfort, Contains: Catnip, Chamomile, Vegetable Glycerin, water; packaged in a 2 oz. glass dropper bottle

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Baby Allergy Herbal Supplement, Contains: Echinacea Purpurea, Oregon Grape Root, Dandelion & Burdock Root, Fenugreek, Ginger Root in vegetable glycerin; packaged in a 2 oz. glass dropper bottle, UPC 249953949282

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10

Presence of Foreign Tablets/Capsules

Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08

Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint

Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.

Subpotent product:out of specification assay results observed during long term stability testing.

Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.

Defective container: cracked/broken cartridges

Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.

Defective container: cracked/broken cartridges

3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.

Defective container: cracked/broken cartridges

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.

Subpotent product:out of specification assay results observed during long term stability testing.

2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.

Defective container: cracked/broken cartridges

OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10

Defective container: cracked/broken cartridges

Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.

Subpotent product:out of specification assay results observed during long term stability testing.

Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05.

Defective container: cracked/broken cartridges

Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.

Defective container: cracked/broken cartridges

Celebration Herbals Senna Leaf Herbal Tea 24 Teabags, net wt. 1.48oz. UPC 628240201829

possible salmonella

SENNA LEAVES F/C OG Item No: SEN15001 Net Wt: 44.75 Lbs Distributed By Whole Herb Company 19800 8th Street East, Sonoma, CA 95476 UPC 10031 44312

Potential contamination with Salmonella.

Pasteurized Donor Human Milk in 4 ounce/120 ml clear plastic bottles. The bottles have a foil seal and are capped with a green lid. Bottle size: 120ml

Foreign object

Belevini BICHKI, Dried Salted Whole Smelts, Net. Weight, 5.29 oz (150 g) VACUUM PACK,20 PACKAGES PER CASE, FROZEN, REFRIGERATE AFTER OPENING

Clostridium botulinum (uneviscerated fish)

Linzer Hearts Baked Cut Out Cookies UPC 0 44964 22072 2 72 - 4.0 oz Cut Cookies CBB-220-LZ Net Weight: 18 lbs Ingredients: Enriched flour (bleached WHEAT flowr, malted barley flour, niacin, iron, thaimine mononitrate, riboflavin, folic acid), butter (pasteurized cream (MILK), salt), granulated sugar, EGGS (whole EGGS, citric acid), raspberry filling (raspberries, corn syrup, sugar, water, contains 2% or less of the following, pectin, citric acid, guar gum, calcium chloride, potassium sorbate (pr

Undeclared Milk and FD&C Blue #1.

BaiLiFeng Dried Cinnamon Powder; Net Wt 4 oz/114G; Good Way Trading Group Inc 58-51 Maspeth Avenue Maspeth NY 11378; Product of China; Ingredients: Dried Cinnamon; UPC code: 4 897055 79940 1

contains high levels of lead (10.7 mg/kg)

Food to Live brand ORGANIC MORINGA LEAF POWDER, packaged heat-sealed, resealable stand-up pouches in 8 oz, 1 lb., 2 lb., 4 lb., 8 lb., 16 lb., and 44 lb. bags; Ingredients: ORGANIC MORINGA LEAF POWDER; UPC: 8 oz - 840374833268 1 lb. - 840374812881 2 lb. - 840374813109 4 lb. - 840374810283 8 lb. - 840374833275 12 lb. - 840374812898 16 lb. - 840374812904 44 lb. - 840374833282

Contaminated with Salmonella

Belevini KORUSHKA, Dried Salted Whole Smelts, Net. Weight, 5.29 oz (150 g) VACUUM PACK, 20 PACKAGES PER CASE, FROZEN, REFRIGERATE AFTER OPENING

Clostridium botulinum (uneviscerated fish)

Chef brand Milk Pan 24cm

Products found to contain leachable lead levels (3.00 mg/L)

Food to Live brand ORGANIC SUPERGREENS POWDER MIX, packaged heat-sealed, resealable stand-up pouches in 8 oz, 1 lb., 1.5 lb., 3 lb., 6 lb., 12 lb.; Ingredients: ORGANIC KALE; ORGANIC MORINGA LEAF; ORGANIC WHEAT GRASS; ORGANIC SPIRULINA UPC: 8 oz. - 810097461475 1 lb. - 810097461482 1.5 lb. - 810097461499 3 lb. - 810097461505 6 lb. - 810097461512 12 lb. - 810097461529

Contaminated with Salmonella

Hollandia Dairy, Inc. 100% Appleberry Juice; Half Pint (236mL). UPC: 0 27495 03679 6

100% Appleberry Juice contaminated with cleaning solution, Peracetic Acid.

Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.

During the week of 15-Nov-2020, Medtronic initiated retrieval activities for 6 devices (5 US/1 OUS) for consignees in possession of potentially affected, non-implanted devices according to Medtronic records. Consignees were either verbally directed by Medtronic Field Representatives to quarantine product, or in the case of consigned units, the product was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The firm will follow with a letter to be disseminated on 12/04/2020 to the risk managers.

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.

Failed stability specifications: Out of specification for hardness test