Home
Disease Vault Drug Index & Alternatives Drug Interactions Pregnancy Drug Safety Drug Recalls & Alerts OTC Navigator
Medical Bot Med Lab Clinical Cases Nutrition & Macro Calculator
Questo Insights Global Opportunities Paper Helper Citation Generator Scholarships & Travel Visa & Mobility Navigator English Assessment Test
Med Jobs Med Lounge Pharma Swap Pharmacies Directory Medical Case Donations Opportunity Crowdfunding
Courses Academy Quiz Arena Memory Palace STEM Academy Toolkits
About Us Contact Us Privacy Policy Terms of Service
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 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 661–680 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0210-2026

CLOTRIMAZOLE

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 Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.
Lots / Batch Codes & Expiration Dates
Lot #: A472408
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0197-2026

PHYTONADIONE

Manufacturer / Recalling Firm: Cipla Limited
Reason for Recall: Failed Stability Specifications: Observed OOS results: eg results for colour index
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96
Lots / Batch Codes & Expiration Dates
Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0209-2026

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, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
Lots / Batch Codes & Expiration Dates
Lot #: A352505
Distribution Scope
USA Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0198-2026

TESTOSTERONE

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Defective Container - A defect in the side-seal which allows leakage of product.
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
Lots / Batch Codes & Expiration Dates
Lot #100068692, Exp.: 04/30/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0207-2026

DYNASHIELD

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
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.
Lots / Batch Codes & Expiration Dates
Lot #: A092421, Exp. Date 7/27, A092340, Exp. Date 10/26 & A092346, Exp. Date 11/26.
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0215-2026

DULOXETINE

Manufacturer / Recalling Firm: Breckenridge Pharmaceutical, Inc.
Reason for Recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
Lots / Batch Codes & Expiration Dates
Lot #: 240947C, 240962C, Exp. Date 04/2027
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0213-2026

MENTHOL AND 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
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
Lots / Batch Codes & Expiration Dates
Lot #: A482305
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0203-2026

SALINE ENEMA

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
Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.
Lots / Batch Codes & Expiration Dates
Lot #: A022310, Exp. Date 2/26; A022335, Exp. Date 10/26; A022406, Exp Date 12/27 & A022505, Exp Date 12/27
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0202-2026

DYNASHIELD

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
Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.
Lots / Batch Codes & Expiration Dates
Lot #: A092334, Exp. Date 6/26 & A092421, Exp. Date 7/27
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0216-2026

DULOXETINE

Manufacturer / Recalling Firm: Breckenridge Pharmaceutical, Inc.
Reason for Recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Lots / Batch Codes & Expiration Dates
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0200-2026

Phenylephrine HCI

Manufacturer / Recalling Firm: Park Avenue Compounding
Reason for Recall: CGMP Deviations
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.
Lots / Batch Codes & Expiration Dates
Lot # 20250813-13D65E, Exp Date: FEB-09-2026.
Distribution Scope
MO
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

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