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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 481–500 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0220-2026

GANIRELIX ACETATE

Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01
Lots / Batch Codes & Expiration Dates
Lot #: WB00006, Exp 12/31/2026
Distribution Scope
FL, MA, MI & OH
Class III (Low Risk)
Drug recall Recall #: D-0223-2026

MORPHINE SULFATE

Manufacturer / Recalling Firm: Winder Laboratories, LLC
Reason for Recall: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
Lots / Batch Codes & Expiration Dates
Lot 1312405; Exp 09/28/2027
Distribution Scope
U.S. Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0219-2026

VARENICLINE TARTRATE

Manufacturer / Recalling Firm: Dr. Reddy's Laboratories, Inc.
Reason for Recall: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Lots / Batch Codes & Expiration Dates
Lot # F2400244, Exp Date: 10/31/2026
Distribution Scope
Distributed Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0217-2026

LANTHANUM CARBONATE

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Failed stability specifications: Out of specification for hardness test
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.
Lots / Batch Codes & Expiration Dates
lot# NB240315, exp 12/31/2025
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0205-2026

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, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.
Lots / Batch Codes & Expiration Dates
Lot #: A062434, Exp. Date 6/27 & A062449, Exp. Date 7/27
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0204-2026

Dynagel

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
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.
Lots / Batch Codes & Expiration Dates
Lot #: A322301, Exp. Date 7/26 & A322302, Exp. Date 8/26
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0211-2026

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 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.
Lots / Batch Codes & Expiration Dates
Lot #: A472418
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0208-2026

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, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.
Lots / Batch Codes & Expiration Dates
Lot #: A352405
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0201-2026

Lanashield Skin Barrier

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
Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.
Lots / Batch Codes & Expiration Dates
Lot #: A162301, Exp. Date 9/26; A162401, Exp. Date 4/27 & A162202, Exp. Date 11/25.
Distribution Scope
USA Nationwide
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

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