Drugs Recalls

17,415 recalls in this category

FDA Drug Class II Ongoing

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

August 27, 2025 DermaRite Industries, LLC 57,837 units units
FDA Drug Class II Ongoing

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

August 27, 2025 DermaRite Industries, LLC 15,267 cartridges units
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC

August 27, 2025 Amerisource Health Services LLC 873 cartons units
FDA Drug Class II Ongoing

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

August 27, 2025 DermaRite Industries, LLC 1,480 packets units
FDA Drug Class II Ongoing

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

August 27, 2025 DermaRite Industries, LLC 2,389 bottles units
FDA Drug Class II Ongoing

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

August 27, 2025 DermaRite Industries, LLC 16,006 units units
FDA Drug Class II Ongoing

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

August 27, 2025 DermaRite Industries, LLC 2,673 tubes units
FDA Drug Class II Ongoing

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 Ber

August 27, 2025 DermaRite Industries, LLC 381,619 units units
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Do

August 27, 2025 Amerisource Health Services LLC 1,062 cartons units
FDA Drug Class II Ongoing

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

August 27, 2025 DermaRite Industries, LLC 37,272 tubes units
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual

August 27, 2025 Amerisource Health Services LLC 1,757 cartons units
FDA Drug Class II Ongoing

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), a

August 27, 2025 DermaRite Industries, LLC 7,736 tubes units
FDA Drug Class II Ongoing

Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01

August 27, 2025 Atlantic Management Resources Ltd. 72 containers units
FDA Drug Class II Ongoing

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

August 27, 2025 DermaRite Industries, LLC 15,465 cartridges units
FDA Drug Class II Ongoing

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

August 27, 2025 DermaRite Industries, LLC 37,379 spray bottles units
FDA Drug Class II Ongoing

Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus Pharmaceutic

August 27, 2025 Zydus Pharmaceuticals USA Inc 270,125 Vials units
FDA Drug Class II Ongoing

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, D

August 27, 2025 DermaRite Industries, LLC 115,994 containers units
FDA Drug Class II Ongoing

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 070

August 27, 2025 DermaRite Industries, LLC 576 containers units
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Indivi

August 27, 2025 Amerisource Health Services LLC 2,708 cartons units
FDA Drug Class I Ongoing

Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem

August 27, 2025 Unichem Pharmaceuticals Usa Inc 230 90-count bottles units
FDA Drug Class II Ongoing

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

August 27, 2025 DermaRite Industries, LLC 57,041 units units
FDA Drug Class II Ongoing

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 S

August 27, 2025 DermaRite Industries, LLC 8,378 containers units
FDA Drug Class II Ongoing

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.

August 27, 2025 DermaRite Industries, LLC 5,876 units units
FDA Drug Class II Ongoing

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

August 27, 2025 DermaRite Industries, LLC 3,178 bottles units
FDA Drug Class II Ongoing

0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.

August 26, 2025 B. Braun Medical Inc 16,228 3000 mL bags units
FDA Drug Class II Ongoing

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.

August 26, 2025 B. Braun Medical Inc 26,316 3000 mL bags units
FDA Drug Class III Ongoing

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

August 25, 2025 Consumer Product Partners, LLC 60 bottles units
FDA Drug Class III Ongoing

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

August 25, 2025 Consumer Product Partners, LLC 1860 bottles units
FDA Drug Class II Ongoing

chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15

August 25, 2025 AvKARE 1512 cartons units
FDA Drug Class II Ongoing

chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15

August 25, 2025 AvKARE 2003 cartons units
FDA Drug Class II Ongoing

Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Dis

August 22, 2025 GRACE & FIRE PTY LTD 44,497 tubes units
FDA Drug Class II Ongoing

Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106

August 22, 2025 GRACE & FIRE PTY LTD 49,275 tubes units
FDA Drug Class II Ongoing

Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.

August 20, 2025 Baxter Healthcare Corporation 13,000 containers units
FDA Drug Class II Ongoing

Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61

August 20, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 26,628 cartons units
FDA Drug Class II Ongoing

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-3

August 20, 2025 Northwind Pharmaceuticals LLC a) 96 bottles, b) 627 bottles, c) 428 bottles, d) 1144 bottles units
FDA Drug Class III Ongoing

READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC

August 19, 2025 Medline Industries, LP 2,680 bottles units
FDA Drug Class II Ongoing

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100 Tablets per bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelph

August 19, 2025 Lannett Company, Inc. 4,848 bottles units
FDA Drug Class I Ongoing

0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09

August 18, 2025 B. Braun Medical Inc 47,148 containers units
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal

August 18, 2025 Amneal Pharmaceuticals LLC 3,363 100-count bottles units
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amnea

August 18, 2025 Amneal Pharmaceuticals LLC 14,923 100-count bottles units
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal

August 18, 2025 Amneal Pharmaceuticals LLC 7,228 100-count bottles units
FDA Drug Class II Ongoing

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal

August 18, 2025 Amneal Pharmaceuticals LLC 60,072 100-count, 73,054 500-count bottles units
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal

August 18, 2025 Amneal Pharmaceuticals LLC 13,130 100-count bottles units
FDA Drug Class I Ongoing

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07

August 18, 2025 B. Braun Medical Inc 46,032 containers units
FDA Drug Class II Ongoing

Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-61

August 13, 2025 Sandoz, Inc 1,680 bottles units
FDA Drug Class II Ongoing

Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc.

August 12, 2025 VIONA PHARMACEUTICALS INC 3960 bottles units
FDA Drug Class II Completed

Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

August 11, 2025 Lannett Company, Inc. 8544 bottles units
FDA Drug Class II Ongoing

Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals

August 8, 2025 Glenmark Pharmaceuticals Inc., USA 22,656 bottles units
FDA Drug Class II Ongoing

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pha

August 8, 2025 Breckenridge Pharmaceutical, Inc 3,591 bottles units
FDA Drug Class II Ongoing

Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Ma

August 7, 2025 Glenmark Pharmaceuticals Inc., USA 6,432 bottles units

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