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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
9 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 1061–1080 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0531-2025

TESTO-200

Manufacturer / Recalling Firm: Advanced Pharmaceutical Technology, Inc.
Reason for Recall: Marketed Without an Approved NDA/ANDA
FDA Report: Jul 02, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01
Lots / Batch Codes & Expiration Dates
Lot P-24-1; Exp. 02/28/2027
Distribution Scope
NY, NJ
Class II (Moderate Risk)
Drug recall Recall #: D-0486-2025

Tirzepatide/Cyanocobalamin Injectable

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
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot: C03125A
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0495-2025

AZELASTINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Apotex Corp.
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
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4
Lots / Batch Codes & Expiration Dates
Batch VD1654, Exp Date: 06/30/2027
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0482-2025

Tirzepatide Injections

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
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot, expiry: H272962, exp 12/5/2025; S5045185, exp 5/20/2025; H272962, exp 12/5/2025; H270625, exp 9/30/2025
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0478-2025

Nicotinamide adenine dinucleotide

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
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot #: O-O8A01-25, Exp 3/7/2025
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0490-2025

SODIUM CHLORIDE

Manufacturer / Recalling Firm: Fresenius Medical Care Holdings, Inc.
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
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Lots / Batch Codes & Expiration Dates
24PU06037, 24PU06038, 24PU06040, 24PU06041, 24PU06042, 24PU06043, 24PU06044, 24PU06045, 24PU0646, 24PU06047, 24PU06048, 24PU06049, 24PU06050, 24PU06052, 24PU06053, 24PU06054 & 24PU06055, Exp Date 11/30/2025; 24SU06001, 24SU06002, 24SU06003, 24SU06004, 24SU06005, 24SU06006, 24SU06007, 24SU06009, 24SU06010, 24SU06011 24SU06012, 24SU06013, 24SU06014,...
Distribution Scope
Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0494-2025

KETOROLAC TROMETHAMINE

Manufacturer / Recalling Firm: Apotex Corp.
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
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2
Lots / Batch Codes & Expiration Dates
Batch TZ1236, Exp Date: 11/30/2025
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0474-2025

Methylcobalamin Injectable

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
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot #: H228307, Exp 12/27/2025
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0473-2025

METOCLOPRAMIDE

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Presence of foreign tablets/capsules.
FDA Report: Jul 02, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.
Lots / Batch Codes & Expiration Dates
Lot#: 5420094, Exp 09/30/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0485-2025

Tirzepatide/Cyanocobalamin Injectable

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
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot: C03065F
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0484-2025

Tirzepatide Injections

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
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot: H388348
Distribution Scope
USA Nationwide
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

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