Home
Disease Knowledge Center Drug Hub Monographs Drug Interactions Pregnancy Drug Safety Drug Recalls & Alerts OTC Navigator
Virtual Simulators Hub Clinical Cases Simulator Nutrition & Macro Calculator
Questo Insights Global Opportunities Hub AI Research Assistant Citation & Reference Generator Scholarships & Essay Planner Visa & Mobility Navigator English Assessment Test
Verified Jobs Board Pharmacy Clearance Pharmacies Directory
Practice Quizzes STEM Academy Toolkits
Medical Case Donations Opportunity Crowdfunding Community Forums Courses Academy
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 501–520 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0206-2026

NIVAGEN ZINC OXIDE

Manufacturer / Recalling Firm: Blossom Pharmaceuticals
Reason for Recall: cGMP deviations
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.
Lots / Batch Codes & Expiration Dates
Lot #: A352318
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0214-2026

HALOPERIDOL LACTATE

Manufacturer / Recalling Firm: Safecor Health, LLC
Reason for Recall: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.
Lots / Batch Codes & Expiration Dates
Lot 25381993 and 25391516, Exp 12/31/2026
Distribution Scope
Distributed in Massachusetts
Class II (Moderate Risk)
Drug recall Recall #: D-0212-2026

ZINC OXIDE 20%

Manufacturer / Recalling Firm: Blossom Pharmaceuticals
Reason for Recall: cGMP deviations
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.
Lots / Batch Codes & Expiration Dates
Lot #: A502404, Exp. Date 2/27; A502405, Exp. Date 2/27; AS02502, Exp. Date 2/28.
Distribution Scope
USA Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0199-2026

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
Lots / Batch Codes & Expiration Dates
Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0196-2026

Dr. Bump Natural Pain Relief Gel

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8
Lots / Batch Codes & Expiration Dates
Lot D54947, exp 4/30/2028
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0179-2026

Walgreens Saline Nasal Spray WITH XYLITOL

Manufacturer / Recalling Firm: Medical Products Laboratories, Inc.
Reason for Recall: Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01
Lots / Batch Codes & Expiration Dates
Lot#: 71409, Expires: 02/28/2027; 71861, Expires: 08/31/2027.
Distribution Scope
Nationwide USA
Class II (Moderate Risk)
Drug recall Recall #: D-0190-2026

Gabriel Mineral Sunscreen SPF 50

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1
Lots / Batch Codes & Expiration Dates
Lot D53371, exp 10/31/2026
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0184-2026

Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17
Lots / Batch Codes & Expiration Dates
Lot Code D54757, exp 3/31/2028
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0193-2026

Elixir by Coco March Mineral Sunscreen SPF 50

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0
Lots / Batch Codes & Expiration Dates
Lot D53682, exp 3/31/2027
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0187-2026

Sea Enzyme Ultra Umbrella Sunscreen SPF 30

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02
Lots / Batch Codes & Expiration Dates
Lot D53950, exp 5/31/2027
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0188-2026

Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02
Lots / Batch Codes & Expiration Dates
Lot D53081, exp 7/31/2026
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0195-2026

CLEARSTEM YOU ARE SUNSHINE SPF 50

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
Lots / Batch Codes & Expiration Dates
Lot D54447, exp 11/30/2027
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0183-2026

Doctor. D. Schwab Mineral Sunscreen SPF 50

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02
Lots / Batch Codes & Expiration Dates
Lot Code D54596, exp 1/31/2028
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0189-2026

Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02
Lots / Batch Codes & Expiration Dates
Lot D54597, exp 1/31/2028
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0185-2026

Doctor D. Schwab Controlling Balm with Tea Tree Oil

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05
Lots / Batch Codes & Expiration Dates
Lot Code D54361, exp 8/31/2027
Distribution Scope
CA, CO, FL, PR, WA
Class I (High Risk)
Drug recall Recall #: D-0182-2026

FAMOTIDINE

Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Lots / Batch Codes & Expiration Dates
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Distribution Scope
Nationwide within the United States as well as AK, HI, and PR.
Class II (Moderate Risk)
Drug recall Recall #: D-0186-2026

Doctor D. Schwab Controlling Cream

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05
Lots / Batch Codes & Expiration Dates
Lot Code D54066, exp 5/31/2027
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0192-2026

Sugared+Bronzed Tinted Mineral Sunscreen SPF 50

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6
Lots / Batch Codes & Expiration Dates
Lot D53797, exp 04/30/27
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0194-2026

Elixir by Coco March Tinted Mineral Sunscreen SPF 50

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8
Lots / Batch Codes & Expiration Dates
Lot D53681, exp 03/31/2027
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0191-2026

Karina Daily Moisturizer SPF 25

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5
Lots / Batch Codes & Expiration Dates
Lot D54098, exp 3/31/2027
Distribution Scope
CA, CO, FL, PR, WA

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