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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 1041–1060 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0499-2025

BUPIVAcaine HCL Sterile injection

Manufacturer / Recalling Firm: Tailstorm Health INC
Reason for Recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.
Lots / Batch Codes & Expiration Dates
Lot #s: 2502005, Exp. 2/20/26; 2502006, Exp 2/23/2026
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0507-2025

GABAPENTIN

Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Defective container; blister packaging inadequately sealed.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61
Lots / Batch Codes & Expiration Dates
Lot# M05205, Exp Date 10/2026
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0501-2025

KETAmine Hydrochloride Injection

Manufacturer / Recalling Firm: Tailstorm Health INC
Reason for Recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.
Lots / Batch Codes & Expiration Dates
Lot: 2502009, Exp. 3/2/2026
Distribution Scope
Nationwide in the US
Class I (High Risk)
Drug recall Recall #: D-0570-2025

PENICILLIN G POTASSIUM

Manufacturer / Recalling Firm: Sandoz Inc
Reason for Recall: Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.
Lots / Batch Codes & Expiration Dates
Lot # PG4360, PG4362, Exp. 11/30/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0502-2025

LIDOcaine HCL Sterile Injection

Manufacturer / Recalling Firm: Tailstorm Health INC
Reason for Recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0037-0.
Lots / Batch Codes & Expiration Dates
Lot #s: 2503004, Exp. 3/23/2026; 2503005, Exp. 3/25/2026
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0500-2025

KETAmine Hydrochloride Injection

Manufacturer / Recalling Firm: Tailstorm Health INC
Reason for Recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.
Lots / Batch Codes & Expiration Dates
Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
Distribution Scope
Nationwide in the US
Class III (Low Risk)
Drug recall Recall #: D-0527-2025

PITAVASTATIN

Manufacturer / Recalling Firm: Orient Pharma Co., Ltd. Yunlin Plant
Reason for Recall: Failed Impurities/Degradation Specifications.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98.
Lots / Batch Codes & Expiration Dates
P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, Exp Date 01/2027.
Distribution Scope
NJ
Class III (Low Risk)
Drug recall Recall #: D-0528-2025

PITAVASTATIN

Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Failed Impurity/Degradation Specifications
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0569-2025

CEFAZOLIN

Manufacturer / Recalling Firm: Sandoz Inc
Reason for Recall: Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
Lots / Batch Codes & Expiration Dates
Lot # PG4360, PG4362, Exp. 11/30/2027
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0506-2025

Orajel Baby

Manufacturer / Recalling Firm: Church & Dwight Inc
Reason for Recall: Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
FDA Report: Jul 09, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.
Lots / Batch Codes & Expiration Dates
All Lots.
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0491-2025

SODIUM CHLORIDE

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
FDA Report: Jul 02, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Lots / Batch Codes & Expiration Dates
Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
Distribution Scope
USA Nationwide
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

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