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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
2 weeks ago
Total FDA Recalls
999
Active / Ongoing
962
Critical (Class I)
45
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
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinib...
Blaine Labs Inc Jul 08, 2026
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Ste...
CareFusion 213, LLC Jul 01, 2026
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides.
CareFusion 213, LLC Jul 01, 2026
Showing 321–340 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0363-2026

Max Packaging Antibacterial Towelette

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01
Lots / Batch Codes & Expiration Dates
Lot #: MN24523, Exp. Date July 2028; MN27123, Exp. Date Aug 2028; MN28223, Exp. Date Sep 2028.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0378-2026

Antimicrobial Alcohol Hand Wipe

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.
Lots / Batch Codes & Expiration Dates
Lot #: MN15423 , MN16422, Exp. Date Apr 2027-Apr; MN26322, MN26322, Exp. Date Aug 2027; MN03423, MN03423, Exp. Date Jan 2028; MN09722, Exp. Date Mar 2027; MN31722, Exp. Date Oct 2027; MN15722, MN13722 Exp. Date Apr 2027; MN31722, Exp. Date Oct 2027; MN09722, Exp. Date Mar 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0355-2026

METOPROLOL SUCCINATE

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Failed Dissolution Specifications
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
Lots / Batch Codes & Expiration Dates
Lot#: a) 0486G251, 0487G251, 0488G251, Exp.: 01/2027; b) 0486G252, 0487G253, 0488G252, Exp.: 01/2027.
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0375-2026

BZK PADS

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01
Lots / Batch Codes & Expiration Dates
Lot #: 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352, Exp. Date Mar 2027; 53518, Exp. Date Jun 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0392-2026

Semaglutide Inj

Manufacturer / Recalling Firm: New Life Pharma LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.
Lots / Batch Codes & Expiration Dates
Lot 241113, Exp Date 11/30/2026 & Lot 250103, Exp Date 1/31/2027
Distribution Scope
OH
Class II (Moderate Risk)
Drug recall Recall #: D-0394-2026

Tirzepatide Inj

Manufacturer / Recalling Firm: New Life Pharma LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
Lots / Batch Codes & Expiration Dates
Lot 240709, exp 7/31/2026
Distribution Scope
OH
Class II (Moderate Risk)
Drug recall Recall #: D-0369-2026

BZK PADS

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02
Lots / Batch Codes & Expiration Dates
Lot #: 52347-R, 52348-R, 52349-R, 52350-R, 52351-R, 52352-R, 53518, 53519, Exp. Date Mar 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0358-2026

FIRST AID ONLY BZK ANTISEPTIC

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04
Lots / Batch Codes & Expiration Dates
Lot #: MN26222, MN34722, MN25922, Exp. Date Nov 2027; MN00523, MN00523, Exp. Date Dec 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0386-2026

MAXIMUM

Manufacturer / Recalling Firm: HTO Nevada Inc. dba Kirkman
Reason for Recall: Stability Data Does Not Support Expiry Date.
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Lots / Batch Codes & Expiration Dates
Lot #: 807CP-0003, Exp. Date 07/31/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0373-2026

FIRST AID ONLY HAND SANITIZING WIPE

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00
Lots / Batch Codes & Expiration Dates
Lot #: MN24922, Exp. Date Aug 2027; MN31122, Exp. Date Oct 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0367-2026

MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02.
Lots / Batch Codes & Expiration Dates
Lot # MN23323, Exp. Date Jul 2028; MN31323, Exp. Date Oct 2028; MN21622, Exp. Date Jul 2027; MN13123, Exp. Date Apr 2028.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0395-2026

Tirzepatide Inj

Manufacturer / Recalling Firm: New Life Pharma LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
Lots / Batch Codes & Expiration Dates
Lot 240709, exp 7/31/2026
Distribution Scope
OH
Class I (High Risk)
Drug recall Recall #: D-0396-2026

Mojo Max Fusion XXX

Manufacturer / Recalling Firm: Mohamed Hagar
Reason for Recall: Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0
Lots / Batch Codes & Expiration Dates
ALL LOTS, exp 12/31/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0364-2026

Savannah Antibacterial Towelettes

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02
Lots / Batch Codes & Expiration Dates
Lot #: MN24623, Exp. Date Jul 2028; MN27023, Exp. Date Aug 2028; MN32423, Exp. Oct 2028; MN300724, Exp. Date Dec 2028.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0371-2026

MED NAP CLEANSING TOWELETTE

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC 0924-0243-01.
Lots / Batch Codes & Expiration Dates
Lot #: 52347, 52348, 52349, 52350, 52351, Exp. Date Mar 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0387-2026

MAXIMUM

Manufacturer / Recalling Firm: HTO Nevada Inc. dba Kirkman
Reason for Recall: Stability Data Does Not Support Expiry Date.
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.
Lots / Batch Codes & Expiration Dates
Lot #: 795CP-0005, Exp. Date 06/30/2026
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0385-2026

FIVE-STAR

Manufacturer / Recalling Firm: HTO Nevada Inc. dba Kirkman
Reason for Recall: Stability Data Does Not Support Expiry Date.
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
Lots / Batch Codes & Expiration Dates
Lot #: 839CP-0016, Exp. Date 03/31/2026; 839CP-0017, Exp. Date 06/30/2026; 839CP-0018, Exp. Date 08/31/2026; 839CP-0019, Exp. Date 10/31/2026; 839CP-0020, Exp. Date 03/31/2027; 839CP-0021, Exp. Date 07/31/2027; 839CP-0022, Exp.Date 11/30/2027; 839CP-0023, Exp. Date 02/29/2028; 839CP-0024, Exp. Date 07/31/2028.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0359-2026

FIRST AID ONLY BZK ANTISEPTIC

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03.
Lots / Batch Codes & Expiration Dates
Lot #: MN34722, MN34722, Exp. Date Nov 2027; MN34722B, Exp. Date Aug 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0368-2026

Wipes Plus

Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01.
Lots / Batch Codes & Expiration Dates
Lot #: MN16022, Exp. Date Aug 2027; MN33922, MN31222, Exp. Date Apr 2027; MN16522, Exp. Date Oct 2027; MN17022, Exp. Date Apr 2027; MN03323, Exp. Date Jan 2028; MN34622, Exp. Date Oct 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0393-2026

Semaglutide Inj.

Manufacturer / Recalling Firm: New Life Pharma LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06
Lots / Batch Codes & Expiration Dates
Lot 240903, exp 9/30/2026
Distribution Scope
OH

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