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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 1101–1120 of 1,170 factual FDA recall reports
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
Class II (Moderate Risk)
Drug recall Recall #: D-0436-2025

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 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02
Lots / Batch Codes & Expiration Dates
Lot B0015, B0016, Exp Date: 05/31/2026; Lot B0020, B0021, B0022, Exp Date: 06/30/2026; Lot B0056, B0057, Exp Date: 07/31/2026; Lot B0108, B0109, B0110, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0433-2025

Maximum Security

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
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01
Lots / Batch Codes & Expiration Dates
Lot B0010, B0017, Exp Date: 05/31/2026; Lot B0028, B0029, B0030, Exp Date: 06/30/2026; Lot B0052, Exp Date: 07/31/2026; Lot B0091, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0442-2025

ESOMEPRAZOLE MAGNESIUM

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
FDA Report: May 28, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
Lots / Batch Codes & Expiration Dates
Lot # M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026.
Distribution Scope
Nationwide -in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0432-2025

Maximum Security

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
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03
Lots / Batch Codes & Expiration Dates
Lot B0008, B0009, B0017, Exp Date: 05/31/2026; Lot B0042, B0043, B0044, Exp Date: 06/30/2026; Lot B0049, B0050, B0051, B0054, B0058, B0059, Exp Date: 07/31/2026; Lot B0061, B0062, B0063, B0064, B0065, B0068, B0069, Exp Date: 08/31/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0445-2025

INDOMETHACIN

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
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.
Lots / Batch Codes & Expiration Dates
Lot#: 18400A, Exp 7/31/2027
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0435-2025

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 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06
Lots / Batch Codes & Expiration Dates
Lot B0027, B0031, Exp Date: 06/30/2026; Lot B0032, Exp Date: 07/31/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0424-2025

Kingskin

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
Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.
Lots / Batch Codes & Expiration Dates
Lot SP28A, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0428-2025

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 Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10096 77158 2.
Lots / Batch Codes & Expiration Dates
Lot SP26A, Exp: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0421-2025

ARTRIDON

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
Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-030-05, UPC 8 10096 77151 3.
Lots / Batch Codes & Expiration Dates
Lot SP25A, Exp Date: 09/30/2026
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