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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 861–880 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0063-2026

Methylene Blue 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
Methylene Blue 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-0065-2026

NAD+

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
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
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0064-2026

N-Acetyl-L-Cysteine 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
N-Acetyl-L-Cysteine 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-0057-2026

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
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-0071-2026

Cerebrolysin 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
Cerebrolysin 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-0062-2026

Magnesium Chloride 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
Magnesium Chloride 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-0051-2026

GHK-Cu

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
GHK-Cu (Copper Peptide) 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-0054-2026

Glycine 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
Glycine 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-0081-2026

Reconstitution XO 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
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% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0675-2025

CARBAMAZEPINE

Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: Failed Dissolution Specifications.
FDA Report: Oct 08, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)
Lots / Batch Codes & Expiration Dates
Lot #: 1024078, Exp. Date 08/31/2026
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0677-2025

KETOROLAC TROMETHAMINE

Manufacturer / Recalling Firm: Apotex Corp.
Reason for Recall: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
FDA Report: Oct 08, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
Lots / Batch Codes & Expiration Dates
Batch # VA0444, exp. date 01/2026 Batch # VA4608, exp. date 01/2026 Batch # TZ7016, exp. date 12/2025 UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0002-2026

ENTECAVIR

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
FDA Report: Oct 08, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Lots / Batch Codes & Expiration Dates
Lot#: E409309, Exp 12/31/2026
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0676-2025

BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION

Manufacturer / Recalling Firm: Apotex Corp.
Reason for Recall: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
FDA Report: Oct 08, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).
Lots / Batch Codes & Expiration Dates
a) lot # VE0614 exp. date 12/2025 UPC:(01)00360505058914 (5 mL) b) lot # VE0616 exp. date 12/2025 UPC:(01)0(03)60505058921 (10 mL)
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0001-2026

ENTECAVIR

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
FDA Report: Oct 08, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Lots / Batch Codes & Expiration Dates
Lot#: E409308, Exp 12/31/2026
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0659-2025

Quick Touch Alcohol Prep Pads

Manufacturer / Recalling Firm: YANGZHOU YULOU PAPER PRODUCTS CO., LTD
Reason for Recall: cGMP Deviations
FDA Report: Oct 01, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.
Lots / Batch Codes & Expiration Dates
Lot #: 20240610, Exp. Date 06/2029
Distribution Scope
N/A
Class III (Low Risk)
Drug recall Recall #: D-0673-2025

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

Manufacturer / Recalling Firm: Granules Pharmaceuticals Inc.
Reason for Recall: Failed Impurities/Degradation Specifications:
FDA Report: Oct 01, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01
Lots / Batch Codes & Expiration Dates
Lot#: GPC250181A, Exp Date: 06-19-2027
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0665-2025

Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10%

Manufacturer / Recalling Firm: Private Label Skin Care Inc.
Reason for Recall: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
FDA Report: Oct 01, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com
Lots / Batch Codes & Expiration Dates
Lot # 58170A and 58172A, Exp Date: 09/2025
Distribution Scope
CA, GA only
Class II (Moderate Risk)
Drug recall Recall #: D-0664-2025

Skin MD by Dr Monika Kiripolsky

Manufacturer / Recalling Firm: Private Label Skin Care Inc.
Reason for Recall: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
FDA Report: Oct 01, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211
Lots / Batch Codes & Expiration Dates
Lot # 58170A and 58172A, Exp Date: 09/2025
Distribution Scope
CA, GA only
Class III (Low Risk)
Drug recall Recall #: D-0674-2025

POVIDONE-IODINE

Manufacturer / Recalling Firm: Medline Industries, LP
Reason for Recall: Subpotent drug
FDA Report: Oct 01, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25
Lots / Batch Codes & Expiration Dates
Lot # 24EJA180, Exp 06/01/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0667-2025

Micronized BPO Gel Cleanser 10%

Manufacturer / Recalling Firm: Private Label Skin Care Inc.
Reason for Recall: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
FDA Report: Oct 01, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave, Ste 200, Sacramento, CA 95825.
Lots / Batch Codes & Expiration Dates
Lot # 58170A and 58172A, Exp Date: 09/2025
Distribution Scope
CA, GA only

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