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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
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 161–180 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0719-2026

ROHTO DIGI-EYE

Manufacturer / Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1
Lots / Batch Codes & Expiration Dates
Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0700-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Major Pharmaceuticals
Reason for Recall: Subpotent Drug
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61
Lots / Batch Codes & Expiration Dates
Lot#: N02212, Exp. Date 07/2026
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0710-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Major Pharmaceuticals
Reason for Recall: Subpotent Drug
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61
Lots / Batch Codes & Expiration Dates
Bag lot #: N02266A, N02266B, Exp. Date 11/2026; Blister lot #: N02266, Exp. Date 11/2026
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0702-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Major Pharmaceuticals
Reason for Recall: Subpotent Drug
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61
Lots / Batch Codes & Expiration Dates
Lot# N02172, exp 07/2026; N02296, N02288, Exp. Date 12/2026
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0727-2026

NAROPIN

Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Presence of Particulate Matter: Hair was found in products
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05
Lots / Batch Codes & Expiration Dates
Lot #: 6133436, Exp. Date 10/2028
Distribution Scope
Nationwide within in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0703-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Major Pharmaceuticals
Reason for Recall: Subpotent Drug
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61
Lots / Batch Codes & Expiration Dates
Lot #: N02310, Exp. Date 01/2027
Distribution Scope
Nationwide in the USA.
Class III (Low Risk)
Drug recall Recall #: D-0758-2026

Trokendi XR

Manufacturer / Recalling Firm: Supernus Pharmaceuticals, Inc.
Reason for Recall: Failed Dissolution Specifications
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.
Lots / Batch Codes & Expiration Dates
Lot # 2075801, Exp Date: 31-Oct-2029.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0711-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Major Pharmaceuticals
Reason for Recall: Subpotent Drug
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61
Lots / Batch Codes & Expiration Dates
Bag lot #: N02167A, Exp. Date 07/2026; Blister lot # N02167, Exp. Date 07/2026
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0722-2026

ROHTO

Manufacturer / Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
Lots / Batch Codes & Expiration Dates
Lot #: 3J1V, Exp. Date 2026/09; 4A1V, Exp. Date 2026/12; 4G1V, 4G2V, Exp. Date 2027/06; 4I1V, Exp. Date 2027/08; 4JIV, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12 ; 5B1V, Exp. Date 2028/01; 5F1V, Exp. Date 2028/05; 5F1VA, Exp. Date 2028/05; 5H1V & 5H1VA, Exp. Date 2028/07; 5J1V, 5J1VA, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6B1V, Exp. Date 20...
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0709-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Major Pharmaceuticals
Reason for Recall: Subpotent Drug
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61
Lots / Batch Codes & Expiration Dates
Bag lot #: N02172A, N02172B, Exp. Date 07/2026; N02288A, N02288B, Exp. Date 12/2026; Blister lot #: N02172, Exp. Date 07/2026; N02288, Exp. Date 12/2026
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0716-2026

ROHTO

Manufacturer / Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Jul 29, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
Lots / Batch Codes & Expiration Dates
Lot #: 3H2V, 3H3V, Exp. Date 2026/07; 3J1V, 3J3V, 3J4V, 3J5V, Exp. Date 2026/09; 3K1V, 3K2V, Exp. Date 2026/10; 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, 4B3V, Exp. Date 2027/01; 4F1V, 4F2V, 4F2V, 4F3V, 4F4V, Exp. Date 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, Exp. Date 2027/06; 4H1V, Exp. Date 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, Exp. Date 2027/08.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0686-2026

Foster & Thrive

Manufacturer / Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.
Lots / Batch Codes & Expiration Dates
Lot:1505161, 1505181, 1505301, 1505382, exp 2027-04.
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0684-2026

GOOD NEIGHBOR PHARMACY EARWAX REMOVAL

Manufacturer / Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.
Lots / Batch Codes & Expiration Dates
Lot: a) 1505334, expires: 2027-04; b) 1505143, 1505151, expires: 2027-04
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0682-2026

AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM

Manufacturer / Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
Lots / Batch Codes & Expiration Dates
Lot: a)1505123, expires: 2027-04; b) 1505131, expires: 2027-04.
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0681-2026

TOPCARE EARWAX REMOVAL KIT

Manufacturer / Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
Lots / Batch Codes & Expiration Dates
Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0678-2026

CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID

Manufacturer / Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,
Lots / Batch Codes & Expiration Dates
Lot: a) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04.
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0687-2026

MEIJER EARWAX REMOVAL KIT

Manufacturer / Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
Lots / Batch Codes & Expiration Dates
Lot:1505344, exp 2027-04.
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0677-2026

NYSTATIN

Manufacturer / Recalling Firm: Padagis US LLC
Reason for Recall: Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Lots / Batch Codes & Expiration Dates
Lot #: 205060, Exp 09/30/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0688-2026

CAREONE EARWAX REMOVAL DROPS

Manufacturer / Recalling Firm: Bell Pharmaceuticals, Inc
Reason for Recall: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.
Lots / Batch Codes & Expiration Dates
Lot:1505141, exp 2027-04.
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0690-2026

CHLORAPREP ONE-STEP

Manufacturer / Recalling Firm: CareFusion 213, LLC
Reason for Recall: Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
FDA Report: Jul 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31
Lots / Batch Codes & Expiration Dates
Lots: 4062535, 4065201, 4066446, Exp. 2/28/2027; 4141090, Exp. 5/31/2027; 4180288, 4197695, 4197697, 4180291, Exp. 6/30/2027; 4219454, 4221945, 4221966, 4222853, 4224361, Exp. 7/31/2027; 4228482, 4248656, 4249026, 4248961, 4249818, 4250729, Exp. 8/31/2027; 5124984, 5127231, 5129058, 5126398, 5129488, Exp. 4/30/2028; 5130576, 5142947, 5147432, 51546...
Distribution Scope
U.S.A. 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

Confirm Action