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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 981–1000 of 18,048 recalls

Class IIOngoing

Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class II

Ongoing

Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

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.

GenoGenix LLC

Microbial Contamination of Sterile Products: elevated endotoxin levels

July 30, 2025 · DrugView details →

Class IIOngoing

CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

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 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)

Exela Pharma Sciences LLC

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

July 30, 2025 · DrugView details →

Class IIOngoing

Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

Cardinal Health Inc.

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

July 30, 2025 · DrugView details →

Class IIOngoing

Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

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 CELIA Health.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

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 CELIA Health, Extension Health and Medical Health Institute (MHI).

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

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 Wellness

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

Class IIOngoing

Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

Cardinal Health Inc.

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

July 30, 2025 · DrugView details →

Class IIOngoing

Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

GenoGenix LLC

Lack of Assurance of Sterility

July 30, 2025 · DrugView details →

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