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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
3 hours 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 501–520 of 1,170 factual FDA recall reports
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
Class II (Moderate Risk)
Drug recall Recall #: D-0361-2026

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 Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00.
Lots / Batch Codes & Expiration Dates
Lot #: MN12121, MN13521, Exp. Date Apr 2026; MN15221, MN16721, MN16921, MN17021, MN17021B, Exp. Date May 2026; MN18521, MN18621, MN18621B, Exp. Date Jun 2026; MN24721, MN25021, Exp. Date Aug 2026; MN01123, Exp. Date Dec 2027; MN27421, MN27721, Exp. Date Sep 2026; MN31321, MN31421, Exp. Date Oct 2026; MN34321, MN34521, MN34721, Exp. Date Nov 2026; M...
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0384-2026

TEMOZOLOMIDE

Manufacturer / Recalling Firm: Rising Pharma Holding, Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Lots / Batch Codes & Expiration Dates
Lot #: 1TM0524003A, Exp. Date 09/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0380-2026

Semaglutide

Manufacturer / Recalling Firm: Harbin Jixianglong Biotech Co., Ltd.
Reason for Recall: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.
Lots / Batch Codes & Expiration Dates
Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0383-2026

MIDODRINE HYDROCHLORIDE

Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Defective container; inadequately sealed blister packaging.
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.
Lots / Batch Codes & Expiration Dates
Lot # N02640, Exp Date: 08/2027
Distribution Scope
Nationwide US.
Class II (Moderate Risk)
Drug recall Recall #: D-0376-2026

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%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.
Lots / Batch Codes & Expiration Dates
Lot #: 53518, 53519, Exp. Date Jun 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0366-2026

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
Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.
Lots / Batch Codes & Expiration Dates
Lot #: MN09322, Exp. Date Mar 2027; MN15222, Exp. Date May 2027; MN21622, Exp. Date Jul 2027; MN31822, Exp. Date Oct 2027; MN06223, MN06323, Exp. Date Feb 2028; MN12523, Exp. Date Apr 2028; MN16123, Exp. Date May 2028; MN20523, MN20623, MN20723, Exp. Date Jun 2028; MN23223, Exp. Date Jul 2028; MN31123, Exp. Date Oct 2028; MN300524, MN300624 MN302...
Distribution Scope
Nationwide within the United States
Class III (Low Risk)
Drug recall Recall #: D-0381-2026

Nilotinib Capsules

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
FDA Report: Mar 11, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
Lots / Batch Codes & Expiration Dates
Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0350-2026

C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS

Manufacturer / Recalling Firm: Wizcure Pharmaa Private Limited
Reason for Recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA Report: Mar 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Lots / Batch Codes & Expiration Dates
All lots
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0344-2026

Agebox iKids-Growth

Manufacturer / Recalling Firm: Agebox
Reason for Recall: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
FDA Report: Mar 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0
Lots / Batch Codes & Expiration Dates
Lot # 23101201 exp 09/2026, 24080801 exp 07/2027, and 25020701 exp 01/2028
Distribution Scope
The product was distributed nationwide in the U.S. Agebox sells its U.S. products through Agebox.com (using Shopify) and Amazon.com. All orders are shipped to customers by Agebox itself; other parties are not involved in the distribution of the physical product.

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