FDA recalls, October 2023: 227 published

53 different companies appear this month.

Risk classification: Class I: 87 · Class II: 130 · Class III: 10

Same month, other agencies:CPSC 17 recallsFSIS 20 recallsNHTSA 84 recalls

Recalls this month

DateProduct
October 25, 2023Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 m…D-0064-2024Pine Pharmaceuticals, LLC
October 25, 2023TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. …D-0046-2024Church & Dwight Inc
October 25, 2023Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dos…D-0048-2024Baxter Healthcare Corporation
October 25, 2023Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmac…D-0059-2024Pine Pharmaceuticals, LLC
October 25, 2023Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown,…D-0049-2024KVK-Tech, Inc.
October 25, 2023Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pin…D-0062-2024Pine Pharmaceuticals, LLC
October 25, 2023Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.Z-0075-2024Olympus Corporation of the Americas
October 25, 2023Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case),…D-0047-2024VistaPharm LLC
October 25, 2023Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.D-0045-2024Dollar Tree Distribution, Inc.
October 25, 2023Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx …D-0058-2024Pine Pharmaceuticals, LLC
October 25, 2023Sunnyside Farms, diced Organic Butternut Squash , 32-oz. , plastic tray, 6 trays per case…F-0295-2024Safeway Fresh Foods LLC
October 25, 2023MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic So…D-0043-2024Imprimis NJOF, LLC
October 25, 2023Small 12- Tea Flavor Assorted Mooncake Gift BoxF-0290-2024Sheng Kee of California, Inc dba Sheng Kee Bakery
October 25, 2023Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx …D-0044-2024SUN PHARMACEUTICAL INDUSTRIES INC
October 25, 2023Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx on…D-0051-2024Pine Pharmaceuticals, LLC
October 25, 2023Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL…D-0056-2024Pine Pharmaceuticals, LLC
October 25, 2023Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by…D-0050-2024Pine Pharmaceuticals, LLC
October 25, 2023Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Comp…D-0061-2024Pine Pharmaceuticals, LLC
October 25, 2023Large 4- Lotus Pine Nut Mooncake Gift BoxF-0291-2024Sheng Kee of California, Inc dba Sheng Kee Bakery
October 25, 2023Small 12 -3 Flavor Assorted Mooncake Gift Box Small 12- 4 Flavor Assorted Mooncake Gift B…F-0288-2024Sheng Kee of California, Inc dba Sheng Kee Bakery
October 25, 2023Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compoun…D-0054-2024Pine Pharmaceuticals, LLC
October 25, 20233 Gallon, plastic container of mint chip flavored ice creamF-0294-2024Katies Korner Inc.
October 25, 2023Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer S…D-0065-2024Pine Pharmaceuticals, LLC
October 25, 2023Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by …D-0052-2024Pine Pharmaceuticals, LLC
October 25, 2023Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use droppe…D-0063-2024Pine Pharmaceuticals, LLC
October 25, 2023Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by…D-0053-2024Pine Pharmaceuticals, LLC
October 25, 2023Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use D…D-0055-2024Pine Pharmaceuticals, LLC
October 25, 2023TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution,…D-0060-2024Pine Pharmaceuticals, LLC
October 25, 2023Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceutic…D-0057-2024Pine Pharmaceuticals, LLC
October 25, 2023Kraft Singles American Pasteurized Prepared Cheese product, 24 individually wrapped slice…F-0296-2024HEINZ
October 25, 2023PAISA Sweet Corn Pancakes, Cachapas de Maiz, NET WT. 24 Oz., 5 units, KEEP REFRIGERATEDF-0297-2024Tama Corporation
October 25, 2023Large 4- Red Bean Mooncake Gift BoxF-0292-2024Sheng Kee of California, Inc dba Sheng Kee Bakery
October 18, 2023LittleOak Natural Goat Milk Follow On Infant Formula (Stage 2); packaged in 800g (1.8lbs)…F-0009-2024The Little Oak Company Ltd
October 18, 2023QUAKER PANCAKES WITH WHOLE GRAIN OATS, NET WT 15.97OZ (1LB)F-0287-2024Comercializadora Pepsico Mexico,
October 18, 2023BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and…D-0042-2024Scynexis, Inc.
October 18, 2023MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1Z-0101-2024Mazor Robotics Ltd
October 18, 2023LittleOak Natural Goat Milk Infant Formula (Stage 1); packaged in 800g (1.8lbs) tin cans …F-0008-2024The Little Oak Company Ltd
October 18, 2023Maisie Jane's Smooth almond butter, 12 oz glass jar, 6 units per case, shelf stableF-0012-2024Maisie Jane's California Sunshine Products Inc.
October 18, 2023Evivo with MCT Oil Infant Probiotic Activated B. infantis EVC001 (ActiBif) For Enteral or…F-0299-2024Infinant Health, LLC
October 18, 2023Ginger Snap Milk Chocolate, 2 oz wrappedF-0011-2024Dick Taylor Inc
October 18, 2023LuLu Chinese Express Korean Noodles (Japchae) w/ Vegetables. Net Wt 16oz.F-0007-2024JX Restaurants, Inc.
October 11, 2023fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935…D-0019-2024Central Admixture Pharmacy Services Inc
October 11, 2023JLM Roasted Salted Pecan Halves, 10oz clear plastic container, 12 per wholesale case. Li…F-0002-2024Lipari Foods Operating Company, LLC.
October 11, 2023Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Mul…D-0041-2024Eugia US LLC
October 11, 2023succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbr…D-0026-2024Central Admixture Pharmacy Services Inc
October 11, 2023Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr…D-0035-2024Dr. Berne's Whole Health Products
October 11, 2023Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac gu…Z-0015-2024Boston Scientific Corporation
October 11, 2023Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded wi…Z-0004-2024ARROW INTERNATIONAL Inc.
October 11, 2023Sweet & Spicy BBQ sauce, Fresh Chile BBQ sweet & Spicy Hot. 16 fluid ounce glass jar 19 f…F-1701-2023The Fresh Chile Company
October 11, 2023HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only,…D-0039-2024Amerisource Health Services LLC

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