Home
Disease Vault Drug Index & Alternatives Drug Interactions Pregnancy Drug Safety Drug Recalls & Alerts OTC Navigator
Medical Bot Med Lab Clinical Cases Nutrition & Macro Calculator
Questo Insights Global Opportunities Paper Helper Citation Generator Scholarships & Travel Visa & Mobility Navigator English Assessment Test
Med Jobs Med Lounge Pharma Swap Pharmacies Directory Medical Case Donations Opportunity Crowdfunding
Courses Academy Quiz Arena Memory Palace STEM Academy Toolkits
About Us Contact Us Privacy Policy Terms of Service
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
8 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 61–80 of 1,170 factual FDA recall reports
Class III (Low Risk)
Drug recall Recall #: D-0833-2026

Trokendi XR

Manufacturer / Recalling Firm: Supernus Pharmaceuticals, Inc.
Reason for Recall: Failed dissolution specifications.
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.
Lots / Batch Codes & Expiration Dates
Lot# 2145283, Exp Date: 31-Mar-2030.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0813-2026

CARDENE IV

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.
Lots / Batch Codes & Expiration Dates
Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0821-2026

Daptomycin

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.
Lots / Batch Codes & Expiration Dates
Lot # NC193856, Exp Date: 04/18/2028.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0811-2026

VASOPRESSIN IN 0.9% SODIUM CHLORIDE

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12.
Lots / Batch Codes & Expiration Dates
Lot # NC193672, NC193795, Exp Date: 04/30/2028; Lot # NC194198, Exp Date: 05/31/2028.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0815-2026

CLINDAMYCIN PHOSPHATE

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: CGMP Deviations
FDA Report: Sep 09, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.
Lots / Batch Codes & Expiration Dates
Lot # NC185424, Exp Date: 2/12/2027; Lot # NC185479, Exp Date: 2/13/2027; Lot # NC193948, Exp Date: 10/23/2027.
Distribution Scope
US Nationwide; Puerto Rico; and Chile.
Class II (Moderate Risk)
Drug recall Recall #: D-0804-2026

Paxil CR

Manufacturer / Recalling Firm: Apotex Corp.
Reason for Recall: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Lots / Batch Codes & Expiration Dates
Lot # TY9494, Exp Date: 05/31/2027.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0780-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17.
Lots / Batch Codes & Expiration Dates
Lot #: D2402443, D2402444, D2402445, Exp. Date 10/31/2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0778-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-17.
Lots / Batch Codes & Expiration Dates
Lot #: D2401813, D2401814, Exp. Date 08/31/2026; D2500200, D2500219, Exp. Date 12/31/2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0779-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Lots / Batch Codes & Expiration Dates
a) Lot #: D2402186, Exp. Date 09/30/2026. b) Lot #: D2402019, Exp. Date 08/31/2026; D2402094, Exp. Date 09/30/2026; D2500022, D2500023, D2500021, Exp. Date 12/31/2026.
Distribution Scope
Nationwide within the United States
Class I (High Risk)
Drug recall Recall #: D-0832-2026

LACTATED RINGERS

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Presence of Particulate matter.
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00
Lots / Batch Codes & Expiration Dates
Lot#: J4H077, Exp 30NOV2026.
Distribution Scope
U.S. Nationwide
Class I (High Risk)
Drug recall Recall #: D-0827-2026

TYENNE

Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.
Lots / Batch Codes & Expiration Dates
Lot: 16UI07, Exp 08/31/2028
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0784-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Lots / Batch Codes & Expiration Dates
a) Lot #: D2402642, Exp. Date 11/30/2026 b) Lot #: D2401832, Exp. Date 08/31/2026; D2402525, D2402527, D2402526, D2402644, D2402643, Exp. Date 11/30/2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0790-2026

Zicam

Manufacturer / Recalling Firm: Church & Dwight Co., Inc.
Reason for Recall: CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
Lots / Batch Codes & Expiration Dates
Lot # UN52882, Exp Date: 04/30/2028; Lot # UN53431, Exp Date: 06/30/2028; Lot # UN60411, Exp Date: 08/31/2028.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0783-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17.
Lots / Batch Codes & Expiration Dates
Lot #: D2402195, D2402196, D2402197, Exp. Date 09/30/2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0803-2026

ACTHAR

Manufacturer / Recalling Firm: Mallinckrodt Hospital Products Inc.
Reason for Recall: Presence of particulate matter: glass and stopper piece
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
Lots / Batch Codes & Expiration Dates
Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0777-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-449-17.
Lots / Batch Codes & Expiration Dates
Lot #: D2402016, D2402017, Exp. Date 08/31/2026
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0786-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15.
Lots / Batch Codes & Expiration Dates
Lot #: D2402337, Exp. Date 10/31/2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0789-2026

CLOBETASOL PROPIONATE

Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: Failed content uniformity specifications.
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
Lots / Batch Codes & Expiration Dates
Lot#: KB00427, Exp date 4/30/2028; KA00308, Exp date 10/31/2026
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0782-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Lots / Batch Codes & Expiration Dates
a) Lot # D2402125, D2402126, D2402127, Exp. Date 09/30/2026. b) Lot #: D2402523, D2402524, Exp. Date 11/30/2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0775-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
FDA Report: Sep 02, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.
Lots / Batch Codes & Expiration Dates
Lot #: D2401927, D2401833, Exp. Date 08/31/2026; D2402551, D2402552, Exp. Date 11/30/2026; D2500220, Exp. Date 12/31/2026; D2500223, Exp. Date 01/31/2027.
Distribution Scope
Nationwide within the United States

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