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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 81–100 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0600-2026

PEARSON TOPICAL ANESTHETIC

Manufacturer / Recalling Firm: Keystone Industries
Reason for Recall: Defective container:may contain bottles with incomplete seals
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3.
Lots / Batch Codes & Expiration Dates
BNZ-001917, Exp 04/01/2029
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0596-2026

BUPRENORPHINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Par Health USA, LLC
Reason for Recall: Crystallization; identified as Buprenorphine free base
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
Lots / Batch Codes & Expiration Dates
Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0631-2026

Circle K

Manufacturer / Recalling Firm: Dabur India Limited
Reason for Recall: CGMP Deviations; deficiencies observed during FDA inspection
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0.
Lots / Batch Codes & Expiration Dates
Lot# 0001, and Lot# 0005, within expiry
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0588-2026

ALYACEN 1/35

Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29
Lots / Batch Codes & Expiration Dates
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Distribution Scope
USA Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0642-2026

Med Pride

Manufacturer / Recalling Firm: Dabur India Limited
Reason for Recall: CGMP Deviations; deficiencies observed during FDA inspection
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8.
Lots / Batch Codes & Expiration Dates
Lot# 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 012, 013, 023, 024, 025, 027, 028, 029, 031, 032, 033, 034, 035, Within Expiry.
Distribution Scope
US Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0608-2026

FOCALIN

Manufacturer / Recalling Firm: Sandoz Inc
Reason for Recall: Labeling: Incorrect or Missing Lot and/or Exp Date
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31
Lots / Batch Codes & Expiration Dates
Lot VA0099422; Exp. Date June 30, 2028
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0638-2026

Med Pride

Manufacturer / Recalling Firm: Dabur India Limited
Reason for Recall: CGMP Deviations; deficiencies observed during FDA inspection
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.
Lots / Batch Codes & Expiration Dates
Lot# 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, Within Expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0606-2026

SAFCO SENSICAINE ULTRA TOPICAL ANESTHETIC GEL

Manufacturer / Recalling Firm: Keystone Industries
Reason for Recall: Defective container:may contain bottles with incomplete seals
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.
Lots / Batch Codes & Expiration Dates
BNZ-001921, Exp 04/15/2029
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0632-2026

Lil Drug Store

Manufacturer / Recalling Firm: Dabur India Limited
Reason for Recall: CGMP Deviations; deficiencies observed during FDA inspection
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 3 66715 97310 8.
Lots / Batch Codes & Expiration Dates
Lot# 0005, within expiry
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0604-2026

DENTAL CITY TOPICAL ANESTHETIC

Manufacturer / Recalling Firm: Keystone Industries
Reason for Recall: Defective container:may contain bottles with incomplete seals
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30
Lots / Batch Codes & Expiration Dates
BNZ-001921, Exp 04/15/2029
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0603-2026

BURKHART TOPICAL ANESTHETIC

Manufacturer / Recalling Firm: Keystone Industries
Reason for Recall: Defective container:may contain bottles with incomplete seals
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30
Lots / Batch Codes & Expiration Dates
BNZ-001917, Exp 04/15/2029
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0594-2026

ARIPIPRAZOLE

Manufacturer / Recalling Firm: Ajanta Pharma USA Inc
Reason for Recall: Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.
Lots / Batch Codes & Expiration Dates
Lot: PA00805, expires: 01/31/2029
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0589-2026

VistaPharm

Manufacturer / Recalling Firm: PAI Holdings LLC
Reason for Recall: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04.
Lots / Batch Codes & Expiration Dates
Lot #: AE001, expires: 5/31/2026.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0591-2026

VistaPharm

Manufacturer / Recalling Firm: PAI Holdings LLC
Reason for Recall: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04.
Lots / Batch Codes & Expiration Dates
Lot #: AE006, expires: 5/31/2026
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0590-2026

VistaPharm

Manufacturer / Recalling Firm: PAI Holdings LLC
Reason for Recall: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08.
Lots / Batch Codes & Expiration Dates
Lot #: AE001, expires: 5/31/2026.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0636-2026

Med Pride

Manufacturer / Recalling Firm: Dabur India Limited
Reason for Recall: CGMP Deviations; deficiencies observed during FDA inspection
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.
Lots / Batch Codes & Expiration Dates
Lot# 001, 002, 003, 004, 005, 006, 010, 011, 012, 013, 014, 016, 017, 018, 019, 020, Within Expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0639-2026

Med Pride

Manufacturer / Recalling Firm: Dabur India Limited
Reason for Recall: CGMP Deviations; deficiencies observed during FDA inspection
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061.
Lots / Batch Codes & Expiration Dates
Lot# 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 014, 015, 017, 018, 019, 020, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 034, 035, 036, 037, 038, 039, 041, 042, 043, 044, 048, 049, 050, 051, 052, 053, 054, 055, 056, 057, 058, 059, 060, 061, 062, 063, 064, Within Expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0629-2026

Lucky Super Soft

Manufacturer / Recalling Firm: Dabur India Limited
Reason for Recall: CGMP Deviations; deficiencies observed during FDA inspection
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5.
Lots / Batch Codes & Expiration Dates
Lot# 0001, 0002, within expiry
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0601-2026

QUALA TOPICAL ANESTHETIC GEL

Manufacturer / Recalling Firm: Keystone Industries
Reason for Recall: Defective container:may contain bottles with incomplete seals
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.
Lots / Batch Codes & Expiration Dates
BNZ-001921, EXP 04/15/2029
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0610-2026

CHLORTHALIDONE

Manufacturer / Recalling Firm: Inventia Healthcare Limited
Reason for Recall: Failed Dissolution Specifications
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10
Lots / Batch Codes & Expiration Dates
[100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
Distribution Scope
U.S. 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