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Week of Oct 13, 2025

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Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

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 labeled as manufactured for CELIA Health — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)Nexus Pharmaceuticals Inc

Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoAvKARE recall (Cls II)AvKare LLC

Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28 — Reason: Failed Content Uniformity Specifications — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)Amneal Pharmaceuticals, Inc.

Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)Eli Lilly and Co

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 and Synergy Wellness 60mg, 10mL vial lyophilized. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

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 Health and Medical Health Institute — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)University of Colorado Denver

Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall (Cls II)Fosun Pharma USA Inc

Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61 — Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)PharmaTher Holdings Ltd

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, 10mL vial lyophilized. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall (Cls II)Fosun Pharma USA Inc

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617 — Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall (Cls II)Fosun Pharma USA Inc

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610 — Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoAcella Pharmaceuticals, LLC recall (Cls II)LIPELLA PHARMACEUTICALS INC.

Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05. — Reason: Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)Tsuno Rice Fine Chemicals Co Ltd

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. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)OT4B

Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoAcuity Specialty Products, Inc. recall (Cls II)Outdoor Specialty Products, Inc.

AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum. — Reason: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded. — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)BTG International Inc

B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall (Cls II)Fosun Pharma USA Inc

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061 — Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)Novo Nordisk AS

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, 10mL vial lyophilized. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

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 Institute (MHI), 10mL. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

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 Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44 billion per vial, 8mL of solution in 10mL vial. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

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 Health and Medical Health Institute (MHI). — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)Renovion Inc

Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

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. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recall (Cls II)Fosun Pharma USA Inc

Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614 — Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoAcuity Specialty Products, Inc. recall (Cls II)Outdoor Specialty Products, Inc.

Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum. — Reason: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded. — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

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. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)Aphios Corp

Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls I)

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. — Reason: Microbial Contamination of Sterile Products: elevated endotoxin levels — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)Novitium Pharma LLC

L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

Oct 15, 2025recall298d agoRC Outsourcing, LLC recall (Cls II)F. Hoffmann-La Roche Ltd

Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436. — Reason: Lack of assurance of sterility. — Status: Terminated

full page →fda recalls ↗

Oct 15, 2025recall298d agoGenoGenix LLC recall (Cls II)

Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. — Reason: Lack of Assurance of Sterility — Status: Ongoing

full page →fda recalls ↗

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