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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
48 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 801–820 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0068-2026

Ultra Burn 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
Ultra Burn 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-0083-2026

Semaglutide with B12 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 with B12 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-0082-2026

Sterile Saline 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
Sterile Saline Reconstitution Solution 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-0045-2026

B6

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
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
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0090-2026

Sermorelin Lyophilized powder for reconstitution

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
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.
Lots / Batch Codes & Expiration Dates
Lot#: GG062425-002 within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0086-2026

BPC-157/Thymosin Beta-4 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/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).
Lots / Batch Codes & Expiration Dates
Lot#: GG020525-001, GG060525-001, GG062625-004, within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0076-2026

Low Solubility Peptide 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
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.
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0056-2026

L-Arginine HCl 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 HCl 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-0008-2026

SUCCINYLCHOLINE

Manufacturer / Recalling Firm: Dr. Reddy's Laboratories, Inc.
Reason for Recall: Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25
Lots / Batch Codes & Expiration Dates
Lot # K250048
Distribution Scope
Nationwide within the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0006-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
Lots / Batch Codes & Expiration Dates
Lot # D2300045, Exp 12/31/2025.
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0087-2026

Thymosin Beta-4

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
Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lots / Batch Codes & Expiration Dates
Lot#: GG060525-001 within expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0041-2026

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, Preserved, 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-0084-2026

Zinc 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
Zinc 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-0003-2026

Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe

Manufacturer / Recalling Firm: RC Outsourcing, LLC
Reason for Recall: Lack of assurance of sterility.
FDA Report: Oct 15, 2025 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot # 20250708-768A26, BUD: Oct 06, 2025 20250715-944DF2 BUD: Oct 13, 2025 20250722-55C603 BUD: Oct 20, 2025 20250722-5DC113 BUD: Oct 20, 2025
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0058-2026

L-Glutamine 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-Glutamine 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-0060-2026

Lipo MIC +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
Lipo MIC +B12 Methylcobalamin 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-0072-2026

CoQ10 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
CoQ10 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 I (High Risk)
Drug recall Recall #: D-0094-2026

NAD+

Manufacturer / Recalling Firm: GenoGenix LLC
Reason for Recall: Microbial Contamination of Sterile Products: elevated endotoxin levels
FDA Report: Oct 15, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot#: GG121624-023, within expiry
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0070-2026

Zinc Sulfate 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
Zinc Sulfate 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-0089-2026

Epithalon 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
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health.
Lots / Batch Codes & Expiration Dates
Lot#: GG053025-002 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