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FDA Enforcement Database

Drug Safety & Recalls Center

Access structured drug recall and safety information sourced directly from the U.S. Food & Drug Administration (FDA) OpenFDA Enforcement API. Stay informed on active market withdrawals, manufacturing defect notices, and drug safety advisories.

Last Synchronized
7 minutes ago
Total FDA Recalls
1,170
Active / Ongoing
1,133
Critical (Class I)
63
Data Provenance & Source Transparency: All drug recall records displayed are retrieved directly from the official U.S. FDA OpenFDA Enforcement API. Questo organizes and presents this data for medical education and research without modifying original regulatory facts. Explore OpenFDA API Documentation →
Medical & Legal Disclaimer: The information on this page is compiled for informational and educational reference only and does not constitute medical advice or clinical diagnosis. Never discontinue, start, or substitute any medication without consulting your prescribing doctor or a licensed pharmacist. For urgent health concerns regarding a recalled product, contact your physician immediately or report adverse events to FDA MedWatch.

Latest Critical Safety Updates (Class I)

Recent FDA enforcement reports involving serious health risk classifications

Class I
THYROID
Superpotent Drug
VITRUVIAS THERAPEUTICS INC Sep 23, 2026
Class I
NYSTATIN
Failed Stability Specifications
SUN PHARMACEUTICAL INDUSTRIES... Sep 23, 2026
Class I
SODIUM CHLORIDE
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic mat...
B BRAUN MEDICAL INC Sep 16, 2026
Showing 821–840 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0078-2026

Pentosan for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0047-2026

B-Complex for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0004-2026

Wyandotte

Manufacturer / Recalling Firm: Acuity Specialty Products, Inc.
Reason for Recall: 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.
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot # C2427010, Exp 9/26/2025; Lot # C2432621, Exp 11/21/2025; Lot # C2501514, Exp 1/15/2026; Lot # C2508606, Exp 3/27/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0050-2026

GAC for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0012-2026

Major ChlorproMAZINE Hydrochloride Tablets

Manufacturer / Recalling Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Reason for Recall: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
Lots N01920, Exp. Date, 12/31/2025, N02023, Exp. Date, 02/28/2026 & N02202, Exp. Date, 06/30/2026
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0043-2026

B12 Methylcobalamin for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0040-2026

Ascorbic Acid

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0075-2026

Elite Stack Reconstitution Solution for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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).
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0074-2026

Elite Stack MSC Exosome Reconstitution Solution for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0080-2026

pH Buffered Reconstitution Solution for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0091-2026

Semaglutide for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot#: GG021125-001, GG031125-017, within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0079-2026

Proline for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0044-2026

B5 Dexpanthenol for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0038-2026

Alpha Lipoic Acid for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0059-2026

Lipo MIC + L-Carnitine for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0009-2026

Major ChlorproMAZINE Hydrochloride Tablets

Manufacturer / Recalling Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Reason for Recall: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
Lots N01943 and Lot N02025, exp. date 02/28/2026
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0073-2026

EDTA for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0042-2026

B12 Hydroxocobalamin for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0005-2026

AFCO

Manufacturer / Recalling Firm: Acuity Specialty Products, Inc.
Reason for Recall: 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.
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot # C2432725, Exp 11/22/2025; Lot # C2508304, Exp 3/24/2026; Lot # C2509304, Exp 4/3/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0077-2026

Oxytocin for Injection

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.

FDA Recall Classes & Health Hazard Definitions

Official regulatory classifications defined by the U.S. Food & Drug Administration (21 CFR Part 7)

FDA Health Hazard Classifications
Class I — High Risk Severity

Class I Recall

Regulatory Definition: A situation in which there is a reasonable probability that exposure to a recalled product will cause serious adverse health consequences or death.

Examples: Microbial contamination of sterile injectables, presence of unlabelled severe allergens, toxic impurities, or dosage potency errors.
Class II — Moderate Risk Severity

Class II Recall

Regulatory Definition: A situation in which exposure to a recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote.

Examples: Sub-potent non-life-sustaining tablets, minor dissolution rate variations, or outer carton label misprints.
Class III — Low Risk Severity

Class III Recall

Regulatory Definition: A situation in which exposure to a recalled product is not likely to cause adverse health consequences, but violates FDA packaging or manufacturing regulations.

Examples: Minor packaging flaws, harmless tablet color variances, or minor typographical errors in package inserts.
Enforcement Action Statuses
Ongoing Action

Ongoing Status

The recall action is actively in progress across supply chains, distributors, healthcare facilities, and retail pharmacies nationwide.

Completed / Terminated

Completed & Terminated Status

The FDA has confirmed that all reasonable efforts have been made to remove or correct the product, and the enforcement file is officially closed.

System Notice

Confirm Action