Safety Recalls
RSS ↗15,259 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 5,251–5,300 of 15,259
- Class II
Drug Recall · July 30, 2025
Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Medical Device Recall · July 30, 2025
Mckesson Medical-Surgical Inc. Corporate Office
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.
- Class II
Drug Recall · July 30, 2025
Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% ExosomLack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also laLack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health anLack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension HealthLack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mLack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health.Lack of Assurance of Sterility
- Class II
Medical Device Recall · July 30, 2025
Contract Medical International GmbH
Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
- Class II
Drug Recall · July 30, 2025
Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health ILack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for ExteLack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Elite Stack Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension HealthLack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. B-Complex with B12 also labeled as manufactured for Synergy Wellness.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as, manufactured for Synergy Wellness.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class I
Drug Recall · July 30, 2025
NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Microbial Contamination of Sterile Products: elevated endotoxin levels
- Class II
Drug Recall · July 30, 2025
L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELILack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy WellnessLack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Also labeled as manufactured for CELIALack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692Lack of Assurance of Sterility
- Class II
Drug Recall · July 30, 2025
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 286Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
- Class II
Drug Recall · July 30, 2025
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.