Home
Disease Knowledge Center Drug Hub Monographs Drug Interactions Pregnancy Drug Safety Drug Recalls & Alerts OTC Navigator
Virtual Simulators Hub Clinical Cases Simulator Nutrition & Macro Calculator
Questo Insights Global Opportunities Hub AI Research Assistant Citation & Reference Generator Scholarships & Essay Planner Visa & Mobility Navigator English Assessment Test
Verified Jobs Board Pharmacy Clearance Pharmacies Directory
Practice Quizzes STEM Academy Toolkits
Medical Case Donations Opportunity Crowdfunding Community Forums Courses Academy
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 921–940 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0455-2025

FLUOXETINE

Manufacturer / Recalling Firm: Torrent Pharma Inc.
Reason for Recall: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
FDA Report: Jun 11, 2025 Status: Completed Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30
Lots / Batch Codes & Expiration Dates
Lot# BDX6K001; Exp. Date 06/30/2025
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0458-2025

HAND SANITIZER

Manufacturer / Recalling Firm: Consumer Product Partners, LLC
Reason for Recall: Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
FDA Report: Jun 11, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0454-2025

INDOMETHACIN

Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: cGMP deviations
FDA Report: Jun 11, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).
Lots / Batch Codes & Expiration Dates
Lot #: 1021950, Exp. 11/30/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0456-2025

FLUOXETINE

Manufacturer / Recalling Firm: Torrent Pharma Inc.
Reason for Recall: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
FDA Report: Jun 11, 2025 Status: Completed Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)
Lots / Batch Codes & Expiration Dates
Lot# BDX6K001; Exp. Date: 06/30/2025
Distribution Scope
U.S. Nationwide.
Class I (High Risk)
Drug recall Recall #: D-0453-2025

ENDURANCE BOOST WITH HORNY GOAT WEED

Manufacturer / Recalling Firm: EnShiShiXiangNiShangMaoYouXianGongSi
Reason for Recall: Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
FDA Report: Jun 04, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N
Lots / Batch Codes & Expiration Dates
Lot: 250214PRO, Expiration Date: 02/14/2027.
Distribution Scope
Nationwide Via Amazon Platform
Class II (Moderate Risk)
Drug recall Recall #: D-0447-2025

BROMFENAC OPHTHALMIC SOLUTION 0.09%

Manufacturer / Recalling Firm: Alembic Pharmaceuticals Limited
Reason for Recall: Failed Impurities/Degradation Specifications
FDA Report: Jun 04, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17
Lots / Batch Codes & Expiration Dates
Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0449-2025

CARVEDILOL

Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
FDA Report: Jun 04, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Lots / Batch Codes & Expiration Dates
[100-Count Bottles] Lot 19231618, exp Mar-25; 19232064, exp Apr-25; 19232324, May-25; 19233369, Exp Jul-25; Lot 19234162, Exp Sep-25; Lot 19240543, Exp Jan-26 [500-Count Bottles] Lots 19231174, 19231199, 19231164, Exp Feb-25, 19231517,19231527, 19231566,19231568,19231595, 19231618,19231634,19231638, 19231448, Exp Mar-25, 19232043,19232051,1...
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0448-2025

CARVEDILOL

Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
FDA Report: Jun 04, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Lots / Batch Codes & Expiration Dates
[100-Count Bottles] Lot 19231450, Exp Mar-25, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lot 19240280, Exp DEC-25 [500-Count Bottles] Lot 19231450, 19231464, 19231471, 19231493, Exp Mar-25, 19232083, 19232103 Exp Apr-25, 19232658, Exp Jun-25; Lot 19233328, 19233343, 19233344, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lots 19234843,...
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0452-2025

THEOPHYLLINE

Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: OOS results reported for the Dissolution (by UV) test.
FDA Report: Jun 04, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01
Lots / Batch Codes & Expiration Dates
Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0450-2025

CARVEDILOL

Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
FDA Report: Jun 04, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05
Lots / Batch Codes & Expiration Dates
Lot, Exp: Lots 19231899, 19231922, 19231927, 19231967, 19231979, Exp Apr-25; Lots 19232226, 19232234, 19232265, 1923227,1 Exp May-25; Lots 19232758, 19232759, 19232762, 19232788, Exp Jun-25
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0451-2025

CARVEDILOL

Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
FDA Report: Jun 04, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0422-2025

CURA HONGOS

Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
FDA Report: May 28, 2025 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.
Lots / Batch Codes & Expiration Dates
Lot SP31A, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0441-2025

CHLORAPREP ONE-STEP

Manufacturer / Recalling Firm: CareFusion 213, LLC
Reason for Recall: Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
FDA Report: May 28, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
Lots / Batch Codes & Expiration Dates
Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
Distribution Scope
Nationwide in the U.S.
Class II (Moderate Risk)
Drug recall Recall #: D-0430-2025

Cinnafresh anticavity gel toothpaste

Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
FDA Report: May 28, 2025 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01
Lots / Batch Codes & Expiration Dates
Lot B0011, B0012, Exp Date: 05/31/2026; Lot B0070, B0074, Exp Date: 08/31/2026; Lot B0075, B0077, B0078, B0079, B0080, B0081, B0082, B0083, B0084, B0085, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0426-2025

KOFAL

Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
FDA Report: May 28, 2025 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3.
Lots / Batch Codes & Expiration Dates
Lot SP30A, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0429-2025

RAPIDOL

Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
FDA Report: May 28, 2025 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9.
Lots / Batch Codes & Expiration Dates
Lot SP27A, Exp: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0425-2025

KOFAL Original

Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
FDA Report: May 28, 2025 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.
Lots / Batch Codes & Expiration Dates
Lost SP21A, Exp Date: 03/31/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0423-2025

CURA HONGOS

Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
FDA Report: May 28, 2025 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.
Lots / Batch Codes & Expiration Dates
Lot SP23A, Exp Date: 03/31/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0446-2025

PHENTERMINE HYDROCHLORIDE

Manufacturer / Recalling Firm: KVK Tech, Inc.
Reason for Recall: cGMP deviations
FDA Report: May 28, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.
Lots / Batch Codes & Expiration Dates
Lot#: 18350A, 18351A, Exp 6/30/2027
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0437-2025

Nature Mint

Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
FDA Report: May 28, 2025 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07
Lots / Batch Codes & Expiration Dates
Lot B0067, Exp Date: 08/31/2026
Distribution Scope
DE and NC

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