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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 881–900 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0487-2025

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: GA37484
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0483-2025

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, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot #BH11235 exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024...
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0481-2025

Semaglutide/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
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot: C03075J, Ex p 7/7/2025
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0496-2025

BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION

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
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3
Lots / Batch Codes & Expiration Dates
Batch VC6058, Exp Date: 10/31/2025
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0476-2025

LL Bioboost 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
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot #: H277639, Exp 6/25/2025
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0477-2025

LX Bioboost Plus

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
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot #: H227226, Exp 12/24/2025; H360175, Exp 6/2/2025; H368308, Exp 6/2/2025; Lot S360175, Exp 6/2/2025
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0489-2025

DOBUTAMINE

Manufacturer / Recalling Firm: Pfizer Inc.
Reason for Recall: Discoloration; discolored solution from cracked vials
FDA Report: Jul 02, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC Carton: 0409-2344-02; NDC Vial: 0409-2344-62
Lots / Batch Codes & Expiration Dates
Lot KA5023, exp 02/28/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0475-2025

CJC-1295 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
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot#: H261968, Exp 12/23/2025; H261358, Exp 5/13/2025
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0479-2025

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, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Lots / Batch Codes & Expiration Dates
Lot #: H270221, Exp 12/26/2025
Distribution Scope
USA Nationwide
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

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