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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 901–920 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0480-2025

Semaglutide

Manufacturer / Recalling Firm: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Jul 02, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot #: C03035J, Exp 7/3/2025, H202959, exp 7/6/2025; AB20N110720 , exp 7/7/2025 ; AB60N1121, exp 7/7/2025; PRX022225-1 , exp 8/24/2025 ; U122024 , exp 10/26/2025
Distribution Scope
USA Nationwide
Class I (High Risk)
Drug recall Recall #: D-0493-2025

UMOVY ACIDO HIALURONICO

Manufacturer / Recalling Firm: Umary-USA.com
Reason for Recall: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
FDA Report: Jun 25, 2025 Status: Completed Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
Lots / Batch Codes & Expiration Dates
All Lots; All Expiration Dates.
Distribution Scope
U.S. Nationwide via internet.
Class II (Moderate Risk)
Drug recall Recall #: D-0472-2025

GENTAMICIN

Manufacturer / Recalling Firm: Eugia US LLC
Reason for Recall: Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
FDA Report: Jun 25, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25
Lots / Batch Codes & Expiration Dates
Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0471-2025

AMAZON BASIC CARE ACETAMINOPHEN

Manufacturer / Recalling Firm: Aurobindo Pharma USA Inc
Reason for Recall: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
FDA Report: Jun 25, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
Lots / Batch Codes & Expiration Dates
Lot#: AEF124004A, Exp date 08/31/2026
Distribution Scope
USA Nationwide.
Class I (High Risk)
Drug recall Recall #: D-0492-2025

UNAVY ACIDO HIALURONICO

Manufacturer / Recalling Firm: Umary-USA.com
Reason for Recall: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
FDA Report: Jun 25, 2025 Status: Completed Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295
Lots / Batch Codes & Expiration Dates
All Lots; All Expiration Dates.
Distribution Scope
U.S. Nationwide via internet.
Class III (Low Risk)
Drug recall Recall #: D-0462-2025

EZETIMIBE AND SIMVASTATIN

Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
Lots / Batch Codes & Expiration Dates
Lot #: 17240195, Exp 01/31/2026.
Distribution Scope
Nationwide USA and PR
Class III (Low Risk)
Drug recall Recall #: D-0470-2025

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Macleods Pharmaceuticals Ltd
Reason for Recall: Presence of a foreign substance: black hair found embedded in tablet.
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.
Lots / Batch Codes & Expiration Dates
Lot #: MLF2401A, Exp 01/31/2026
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0463-2025

Male Ultra

Manufacturer / Recalling Firm: SAINI TRADE INC
Reason for Recall: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
Lots / Batch Codes & Expiration Dates
All Lots Lot #: KT-1ST-43-01-10-2025, Exp. 01/10/2027
Distribution Scope
Nationwide
Class I (High Risk)
Drug recall Recall #: D-0464-2025

MALEXTRA

Manufacturer / Recalling Firm: SAINI TRADE INC
Reason for Recall: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
Lots / Batch Codes & Expiration Dates
All lots Lot #: KT-1ST-43-01-04/2026, Exp. 04/25/2026
Distribution Scope
Nationwide
Class I (High Risk)
Drug recall Recall #: D-0467-2025

Male Ultra Pro

Manufacturer / Recalling Firm: SAINI TRADE INC
Reason for Recall: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Lots / Batch Codes & Expiration Dates
All lots Lot #: KT-1ST-43-0110/2025, Exp. 03/15/2026
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0468-2025

CEPHALEXIN

Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin...
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88
Lots / Batch Codes & Expiration Dates
Lot #: 23141828, 23141829, Exp Date: 5/31/2025; 23142342, Exp Date: 6/30/2025; 23142708, Exp Date: 7/31/2025; 23144035, Exp Date: 10/31/2025; 23144270, Exp Date: 11/302025; 24140026, Exp Date: 12/31/2025
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0460-2025

CELECOXIB

Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
Lots / Batch Codes & Expiration Dates
Lot #47881, Exp 05/31/2026
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0466-2025

ULTRA ARMOR

Manufacturer / Recalling Firm: SAINI TRADE INC
Reason for Recall: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
Lots / Batch Codes & Expiration Dates
All lots Lot #: KT-1ST-43-01-10/2025, Exp. 01/10/2027
Distribution Scope
Nationwide
Class I (High Risk)
Drug recall Recall #: D-0488-2025

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Manufacturer / Recalling Firm: Amneal Pharmaceuticals, LLC
Reason for Recall: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Lots / Batch Codes & Expiration Dates
Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0459-2025

CELECOXIB

Manufacturer / Recalling Firm: Alembic Pharmaceuticals Limited
Reason for Recall: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71
Lots / Batch Codes & Expiration Dates
Batch 2405014780, Exp. Date: Sep. 30, 2027
Distribution Scope
Distributed Nationwide and in PR
Class II (Moderate Risk)
Drug recall Recall #: D-0469-2025

CEPHALEXIN

Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin...
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
Lots / Batch Codes & Expiration Dates
Lot #: 23142343, Exp Date: 6/30/2025; 23143526, Exp Date: 9/30/2025; 23144036, Exp Date: 10/31/2025; 23144269, Exp Date: 11/30/2025; Lot 24140027, Exp Date: 12/31/2025; 24144282, Exp Date: 10/31/2026
Distribution Scope
Nationwide in the USA.
Class I (High Risk)
Drug recall Recall #: D-0465-2025

ELECTRO BUZZ

Manufacturer / Recalling Firm: SAINI TRADE INC
Reason for Recall: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
Lots / Batch Codes & Expiration Dates
All lots Lot #: KT-1ST-43-01-07/2024, Exp. 10/15/2026
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0461-2025

CHLORTHALIDONE

Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Failed Dissolution Specifications
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
Lots / Batch Codes & Expiration Dates
Lot # 47947, Exp 05/31/2026
Distribution Scope
Nationwide USA
Class II (Moderate Risk)
Drug recall Recall #: D-0497-2025

ICOSAPENT ETHYL

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
FDA Report: Jun 18, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
Lots / Batch Codes & Expiration Dates
Lot #s: B237040, B237041, Exp 10/31/2025
Distribution Scope
IL, PA, & MS
Class II (Moderate Risk)
Drug recall Recall #: D-0457-2025

Lacosamide Oral Solution

Manufacturer / Recalling Firm: Apotex Corp.
Reason for Recall: Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
FDA Report: Jun 11, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4
Lots / Batch Codes & Expiration Dates
Batch # TZ5589, Exp Date: 01/31/2026
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