Drugs Recalls

17,415 recalls in this category

FDA Drug Class III Terminated

Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-0

October 20, 2023 Edenbridge Pharmaceuticals, LLC 4548 bottles units
FDA Drug Class III Ongoing

Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11

October 20, 2023 Zyla Life Sciences US Inc. 3,792 bottles units
FDA Drug Class II Ongoing

DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4

October 20, 2023 Omega & Delta Co., Inc. 48,145 4 oz bottles units
FDA Drug Class I Ongoing

Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598

October 20, 2023 Botanical Be
FDA Drug Class II Terminated

Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey

October 20, 2023 Sun Pharmaceutical Industries Inc. 2304 Bottles units
FDA Drug Class II Ongoing

Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30

October 20, 2023 Glenmark Pharmaceuticals Inc., USA 5,856 bottles units
FDA Drug Class III Terminated

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufacture

October 20, 2023 Glenmark Pharmaceuticals Inc., USA 480 100-count bottles units
FDA Drug Class I Ongoing

Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF,

October 20, 2023 Botanical Be 235 bottles units
FDA Drug Class II Ongoing

Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9

October 20, 2023 Omega & Delta Co., Inc. 4,848 7.5 oz bottles units
FDA Drug Class II Ongoing

DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4

October 20, 2023 Omega & Delta Co., Inc. 23,136 8 OZ bottles units
FDA Drug Class II Terminated

Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 19312 USA NDC:70726-0303-1 (carton) and 70726-0303-2

October 20, 2023 ITF PHARMA INC 1,792 bottles units
FDA Drug Class II Terminated

Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey N

October 20, 2023 Sun Pharmaceutical Industries Inc. 7392 Bottles units
FDA Drug Class II Completed

Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-2

October 19, 2023 Zydus Pharmaceuticals USA Inc
FDA Drug Class II Completed

Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-25

October 19, 2023 Zydus Pharmaceuticals USA Inc
FDA Drug Class II Completed

Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-2

October 19, 2023 Zydus Pharmaceuticals USA Inc
FDA Drug Class II Terminated

Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15

October 19, 2023 Safecor Health, LLC 166,022 bottles units
FDA Drug Class I Terminated

Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16

October 18, 2023 VistaPharm LLC 180 bottles units
FDA Drug Class I Ongoing

Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to Use For Intravenous Infusion Only Preservative Free, Rx Only, Manufactured and Di

October 18, 2023 Exela Pharma Sciences LLC 23,425 vials units
FDA Drug Class I Ongoing

ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences

October 18, 2023 Exela Pharma Sciences LLC 38,200 vials units
FDA Drug Class II Terminated

Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the

October 18, 2023 Integrity Bio-Chemicals LLC 1-55 gallon drum units
FDA Drug Class I Ongoing

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1;

October 18, 2023 Exela Pharma Sciences LLC 355,220 vials units
FDA Drug Class II Terminated

Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the US

October 18, 2023 Integrity Bio-Chemicals LLC 1 55-gallon drum units
FDA Drug Class II Terminated

Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the US

October 18, 2023 Integrity Bio-Chemicals LLC 1 55-gallon drum units
FDA Drug Class III Terminated

Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08

October 17, 2023 VistaPharm LLC Prod Lot number 22ZKY1, EXP 11/27/23, 600 bottles dist; 22ZMC1 EXP12/21/23 600 bottles; 22ZTP1 EXP 03/29/24 588 bottles; 23ZAD1 EXP 07/07/24 564 bottl units
FDA Drug Class III Ongoing

Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11

October 17, 2023 AbbVie Inc. 864 cartons units
FDA Drug Class I Ongoing

THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7

October 16, 2023 Noah's Wholesale LLC 173 capsules units
FDA Drug Class II Terminated

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.

October 13, 2023 Dr. Reddy's Laboratories, Inc. 1,656 bottles units
FDA Drug Class II Ongoing

Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.

October 5, 2023 Dollar Tree Distribution, Inc. 4,261,383 units of various products units
FDA Drug Class II Terminated

Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL

October 4, 2023 MEDLINE INDUSTRIES, LP - Northfield
FDA Drug Class III Terminated

Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70

October 4, 2023 Denver Solutions, LLC DBA Leiters Health 6,276 IV bags units
FDA Drug Class III Terminated

Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutic

October 4, 2023 Sun Pharmaceutical Industries Inc. 144 bottles units
FDA Drug Class III Terminated

VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.

October 4, 2023 Denver Solutions, LLC DBA Leiters Health 33,480 IV Bags units
FDA Drug Class III Terminated

VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.

October 4, 2023 Denver Solutions, LLC DBA Leiters Health 25,908 IV bags units
FDA Drug Class III Terminated

Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 E

October 3, 2023 Imprimis NJOF, LLC 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag) units
FDA Drug Class I Terminated

1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 040

October 2, 2023 Pfizer Inc. 21,390 vials units
FDA Drug Class II Terminated

Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 2181 droppers units
FDA Drug Class II Terminated

Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 136 syringes units
FDA Drug Class II Terminated

Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 2862 Syringes units
FDA Drug Class II Terminated

Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 662 dropper units
FDA Drug Class II Terminated

Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 201 kits units
FDA Drug Class II Terminated

Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 26 vials units
FDA Drug Class II Terminated

Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 881 pre-filled syringes units
FDA Drug Class II Terminated

Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 9673 vials units
FDA Drug Class II Terminated

Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 4972 syringes units
FDA Drug Class II Terminated

Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 2176 syringes units
FDA Drug Class II Terminated

Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 130 units
FDA Drug Class I Terminated

2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 04

October 2, 2023 Pfizer Inc. 3,200 vials units
FDA Drug Class II Terminated

Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 1598 droppers units
FDA Drug Class II Terminated

Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 141

October 2, 2023 Pine Pharmaceuticals, LLC 2484 syringes units
FDA Drug Class II Terminated

TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

October 2, 2023 Pine Pharmaceuticals, LLC 1693 droppers units

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