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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 hours ago
Total FDA Recalls
1,244
Active / Ongoing
1,207
Critical (Class I)
66
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
ARGATROBAN
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene...
Par Health USA, LLC Oct 28, 2026
Class I
Glutathione Injection
Microbial Contamination of Sterile Products
Greenwich Rx Oct 28, 2026
Class I
ARGATROBAN
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene...
Par Health USA, LLC Oct 28, 2026
Showing 1241–1244 of 1,244 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0379-2025

DoloDent Maximum Strength Toothache Drops

Manufacturer / Recalling Firm: Pharmadel, LLC
Reason for Recall: cGMP deviations
FDA Report: Apr 30, 2025 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15
Lots / Batch Codes & Expiration Dates
Lot EDD-01
Distribution Scope
DE
Class II (Moderate Risk)
Drug recall Recall #: D-0384-2025

Urodel

Manufacturer / Recalling Firm: Pharmadel, LLC
Reason for Recall: cGMP deviations
FDA Report: Apr 30, 2025 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30
Lots / Batch Codes & Expiration Dates
Lot, expiry: UDE-01, EXP: OCT 26
Distribution Scope
DE
Class II (Moderate Risk)
Drug recall Recall #: D-0374-2025

Rocuronium Bromide 50 mg per 5mL

Manufacturer / Recalling Firm: Denver Solutions, LLC DBA Leiters Health
Reason for Recall: Lack of Assurance of Sterility: Leaking/damaged syringes.
FDA Report: Apr 30, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
Lots / Batch Codes & Expiration Dates
Lot #:2530023, Exp.: 7/12/2025
Distribution Scope
Nationwide in the U.S.A
Class II (Moderate Risk)
Drug recall Recall #: D-0375-2025

Hemopropin Ointment

Manufacturer / Recalling Firm: Apipharma
Reason for Recall: CGMP Deviations
FDA Report: Apr 30, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318
Lots / Batch Codes & Expiration Dates
Lot #: A00001, Exp.: 2027-12; A00005, Exp.: 2027-01; B00001, Exp.:2028-02
Distribution Scope
AZ

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