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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 841–860 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0053-2026

Glutathione Preserved 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
Glutathione Preserved 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-0052-2026

Glutathione Magnesium 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
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.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0014-2026

DOXYCYCLINE

Manufacturer / Recalling Firm: Acella Pharmaceuticals, LLC
Reason for Recall: Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Lots / Batch Codes & Expiration Dates
Lot #: P24ZLK1, Exp 5/31/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0010-2026

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, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610
Lots / Batch Codes & Expiration Dates
Lots N01954, Exp. Date, 11/30/2025 & N02024, Exp. Date, 02/28/2026
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0011-2026

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, 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
Lots / Batch Codes & Expiration Dates
Lots N02009 & N02026, exp. date 02/28/2026
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0093-2026

Retatrutide 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
Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lots / Batch Codes & Expiration Dates
Lot#: GG021125-019, within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0085-2026

BPC-157 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
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.
Lots / Batch Codes & Expiration Dates
Lot#: GG012825-002 within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0069-2026

Vitamin D3 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
Vitamin D3 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-0013-2026

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, 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
Lots / Batch Codes & Expiration Dates
Lots N01928, Exp. Date, 09/30/2025, N02008, Exp. Date, 03/21/2026 & N02071, Exp. Date 02/28/2026
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0067-2026

Tri-Immune 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
Tri-Immune 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-0055-2026

L-Arginine 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-Arginine 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-0066-2026

Taurine 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
Taurine 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-0046-2026

Bacteriostatic Water 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
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
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0092-2026

Tirzepatide

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
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.
Lots / Batch Codes & Expiration Dates
Lots GG012925-005, GG021125-003, within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0088-2026

Tesamorelin 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
Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lots / Batch Codes & Expiration Dates
Lot#: GG020425-004 within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0039-2026

Amino Blend 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
Amino Blend 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-0049-2026

Calcium 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
Calcium 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-0048-2026

Biotin 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
Biotin 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-0061-2026

Lysine 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
Lysine 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-0007-2026

NORGESTIMATE AND ETHINYL ESTRADIOL

Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Failed Content Uniformity Specifications
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
Lot # LF41138A; Exp 06/30/2027
Distribution Scope
U.S. 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