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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
4 hours ago
Total FDA Recalls
1,244
Active / Ongoing
1,207
Critical (Class I)
66
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
ARGATROBAN
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene...
Par Health USA, LLC Oct 28, 2026
Class I
Glutathione Injection
Microbial Contamination of Sterile Products
Greenwich Rx Oct 28, 2026
Class I
ARGATROBAN
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene...
Par Health USA, LLC Oct 28, 2026
Showing 1181–1200 of 1,244 factual FDA recall reports
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
Class II (Moderate Risk)
Drug recall Recall #: D-0427-2025

Optim V

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
Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6.
Lots / Batch Codes & Expiration Dates
Lot SP24A, Exp: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0431-2025

Maximum Security 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
Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02
Lots / Batch Codes & Expiration Dates
Lot B0009, B0017, Exp Date: 05/31/2026; Lot B0018, B0019, B0036, B0037, B0038, Exp Date: 06/30/2026; Lot B0049, Exp Date: 07/31/2026; B0063, Exp Date: 08/31/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0443-2025

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, 20 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 68382-848-94
Lots / Batch Codes & Expiration Dates
Lot #:M402147, Exp 10/2025; M311637, Exp 07/2025; M402495, Exp 02/2026; M407997, Exp 05/2026; M502246, Exp11/2026.
Distribution Scope
Nationwide -in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0434-2025

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 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04
Lots / Batch Codes & Expiration Dates
Lot B0013, Exp Date: 05/31/2026; Lot B0018, Exp Date: 06/30/2026; Lot B0053, B0054, Exp Date: 07/31/2026; Lot B0090, B0091, B0092, B0093, B0094, B0095, B0096, B0097, B0098, B0099, B0100, B0101, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0440-2025

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 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05
Lots / Batch Codes & Expiration Dates
Lot B0032, B0047, B0048, B0055, B0056, Exp Date: 07/31/2026; B0102, B0103, B0104, B0105, B0106, B0107, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall Recall #: D-0439-2025

Nature Mint Anticavity Fluoride 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
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04
Lots / Batch Codes & Expiration Dates
Lot B0004, Exp Date: 05/31/2026; B0060, Exp Date: 07/31/2026; Lot B0067, B0071, B0072, Exp Date: 08/31/2026; Lot B0107, B0108, 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