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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 221–240 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0531-2026

SODIUM CHLORIDE

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
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
USA Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0458-2026

CARING MILL COUGH DROPS CHERRY

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
caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count bag, Distributed by: FSA Store Inc., 5473 Blair Rd, Suite 100, PMB 24308, Dallas TX 75231, Made in China, NDC: 83698-421-90, UPC: 810025928407.
Lots / Batch Codes & Expiration Dates
Lot # 20241030, Exp Date: 10/30/2026
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0455-2026

SLMD Benzoyl Peroxide Acne Lotion

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
SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.
Lots / Batch Codes & Expiration Dates
Lot# 2691700, Exp.10/31/2027 Lot# 2691800, Exp. 11/4/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0470-2026

QUALITY CHOICE COUGH DROPS VANILLA HONEY

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, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411.
Lots / Batch Codes & Expiration Dates
Lot # 20240720, Exp Date: 07/20/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0457-2026

MENTHOL FLAVOR COUGH DROP

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
exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC: 83698-581-30, UPC: 614299398887.
Lots / Batch Codes & Expiration Dates
Lot # 20241030, Exp Date: 10/30/2026
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0467-2026

QUALITY CHOICE COUGH DROPS CREAMY STRAWBERRY

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, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Strawberry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-625-30, UPC: 635515999398.
Lots / Batch Codes & Expiration Dates
Lot # 20240720, Exp Date: 07/20/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0464-2026

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, Sugar Free, Black Cherry Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.
Lots / Batch Codes & Expiration Dates
Lot# 20240720, Exp Date: 07/20/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0485-2026

MEMANTINE HYDROCHLORIDE

Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Failed Dissolution Specifications
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
Lots / Batch Codes & Expiration Dates
Lot # N02425, Exp Date: 05/31/2027.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0468-2026

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, Honey Lemon Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-617-30, UPC: 63551598673.
Lots / Batch Codes & Expiration Dates
Lot # 20240720, Exp Date: 07/20/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0475-2026

FLUOCINONIDE

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1
Lots / Batch Codes & Expiration Dates
Lot# AD76252, Exp Date: 6/30/2026.
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0459-2026

DISCOUNT DRUG MART

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
Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio, 44256, Made in China, NDC: 83698-150-30, UPC: 093351037092.
Lots / Batch Codes & Expiration Dates
Lot # 20241030, Exp Date: 10/30/2026
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0479-2026

Albuterol Sulfate Inhalation Solution

Manufacturer / Recalling Firm: Nephron SC, LLC
Reason for Recall: Labelling: Illegible label
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL Sterile Unit-Dose Vials, Rx only, nephron 503B Outsourcing facility, 4600 12th Street Extension, West Columbia, SC 29172, NDC 69374-330-05.
Lots / Batch Codes & Expiration Dates
Lot AB6001, exp date 1/15/2027
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0466-2026

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, Sugar Free, Honey Lemon Flavor, 25-count bag, Distributed By: CDMA, Inc., Novi, MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.
Lots / Batch Codes & Expiration Dates
Lot # 20240720, Exp Date: 07/20/2026, Lot # 20241030, Exp Date: 10/30/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0451-2026

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, 90 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: 69097-412-02
Lots / Batch Codes & Expiration Dates
Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0477-2026

FLUOCINONIDE

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3.
Lots / Batch Codes & Expiration Dates
Lot# AD76250, Exp Date: 6/30/2026.
Distribution Scope
Nationwide in the USA.
Class III (Low Risk)
Drug recall Recall #: D-0482-2026

Essential Calming Skin Gel

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
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
Lots / Batch Codes & Expiration Dates
Lot 4212D4; Exp. 07/31/2026
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0454-2026

SLMD BP Acne Spot Treatment

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
SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.
Lots / Batch Codes & Expiration Dates
Lot# 2567200, Exp.8/1/26 Lot# 2691600, Exp.10/30/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0483-2026

EPINEPHRINE

Manufacturer / Recalling Firm: International Medication Systems 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
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
Lots / Batch Codes & Expiration Dates
Lot Number: EA038A5, Expiration Date: 08/2026.
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0510-2026

DESMOPRESSIN ACETATE

Manufacturer / Recalling Firm: Apotex Corp.
Reason for Recall: Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
FDA Report: Apr 22, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0
Lots / Batch Codes & Expiration Dates
Lot #: VM4231, Exp 06/30/2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0449-2026

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, 30 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: 69097-410-02
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026; Lot 5PB0173, exp January-2027
Distribution Scope
Nationwide in the USA

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