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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
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 201–220 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0495-2026

STERILE WATER

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
Lots / Batch Codes & Expiration Dates
Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0497-2026

SODIUM CHLORIDE FOR IRRIGATION

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
Lots / Batch Codes & Expiration Dates
Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0521-2026

CLARAVIS

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Lots / Batch Codes & Expiration Dates
Lots#: 100067507, 100067508, Exp 07/31/2026
Distribution Scope
Nationwide in the USA, Puerto Rico and Virgin Islands
Class II (Moderate Risk)
Drug recall Recall #: D-0498-2026

LACTATED RINGERS IRRIGATION

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
Lots / Batch Codes & Expiration Dates
Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.
Distribution Scope
US Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0490-2026

MONSELS SOLUTION

Manufacturer / Recalling Firm: Premier Dental Products Co
Reason for Recall: Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vi...
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.
Lots / Batch Codes & Expiration Dates
Lot #: 640911253, Exp Date. 09/14/2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0486-2026

FUROSEMIDE

Manufacturer / Recalling Firm: Leading Pharma, LLC
Reason for Recall: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Lots / Batch Codes & Expiration Dates
Lots# H03125, H03225, H03325, Exp Date: 2027/08
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0496-2026

DEXTROSE

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
Lots / Batch Codes & Expiration Dates
Lot # J5H166, J5H167, Exp Date: 30NOV2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0489-2026

FRESHKOTE LUBRICANT EYEDROPS

Manufacturer / Recalling Firm: Harrow Eye LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Lots / Batch Codes & Expiration Dates
Lot #: 1X68, 1X69, Exp. Date 05/31/2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0493-2026

OMEGA-3-ACID ETHYL ESTERS

Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
FDA Report: Apr 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
Lots / Batch Codes & Expiration Dates
Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0465-2026

QUALITY CHOICE

Manufacturer / Recalling Firm: Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Reason for Recall: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.
Lots / Batch Codes & Expiration Dates
Lot # 20240524, Exp Date: 05/24/2026; Lot # 20240720, Exp Date: 07/20/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0532-2026

LIDOCAINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Huons Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
USA Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0463-2026

MGC HEALTH

Manufacturer / Recalling Firm: Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Reason for Recall: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 383173000030.
Lots / Batch Codes & Expiration Dates
Lot# 20240730, Exp Date: 07/30/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0487-2026

Blemish Spot Treatment

Manufacturer / Recalling Firm: Island Kinetics, Inc. d.b.a. CoValence Laboratories
Reason for Recall: Failed Stability Specifications
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Lots / Batch Codes & Expiration Dates
Lot#: 4228D2, 4229D1, Exp.: 07/31/2026 Lot#: 5147D2, Exp.: 04/30/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0453-2026

HydroPeptide CLEAR ALLIANCE SERUM

Manufacturer / Recalling Firm: Owen Biosciences Inc.
Reason for Recall: Chemical contamination: Presence of benzene
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027
Lots / Batch Codes & Expiration Dates
Lot# 2518800, Exp.: 4/30/2027 Lot# 2518900, Exp.: 4/1/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0469-2026

QUALITY CHOICE

Manufacturer / Recalling Firm: Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Reason for Recall: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-675-30, UPC: 635515986718.
Lots / Batch Codes & Expiration Dates
Lot # 20240720, Exp Date: 07/20/2026; Lot # 20240524, Exp Date: 05/24/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0529-2026

LIDOCAINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Huons Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
USA Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0488-2026

Magnesium Chloride

Manufacturer / Recalling Firm: Avantor Performance Materials LLC
Reason for Recall: Subpotent drug
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1
Lots / Batch Codes & Expiration Dates
Lot 23G3161005, Exp 9/21/2027
Distribution Scope
Nationwide in the USA, Belgium and France
Class II (Moderate Risk)
Drug recall Recall #: D-0530-2026

BUPIVACAINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Huons Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
USA Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0450-2026

CINACALCET

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
Lots / Batch Codes & Expiration Dates
Lot, expiry: 4PB0215, 4PB0216, exp March-2026; 4PB0515, 4PB0516, exp September-2026; 4PB0517, exp September-2026; 5PB0167, exp January-2027
Distribution Scope
Nationwide in the USA
Class III (Low Risk)
Drug recall Recall #: D-0481-2026

Skin Rehab

Manufacturer / Recalling Firm: Island Kinetics, Inc. d.b.a. CoValence Laboratories
Reason for Recall: Subpotent Drug
FDA Report: Apr 22, 2026 Status: Terminated Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
Lots / Batch Codes & Expiration Dates
Lot 4212D2; Exp. 07/03/2026
Distribution Scope
U.S. 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

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