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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
4 minutes ago
Total FDA Recalls
1,278
Active / Ongoing
1,241
Critical (Class I)
66
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
ARGATROBAN
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene...
Par Health USA, LLC Oct 28, 2026
Class I
Glutathione Injection
Microbial Contamination of Sterile Products
Greenwich Rx Oct 28, 2026
Class I
ARGATROBAN
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene...
Par Health USA, LLC Oct 28, 2026
Showing 1–20 of 1,278 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0095-2027

Handtastic Foamy Mango Antiseptic Foam Soap Hand & Body Wash

Manufacturer / Recalling Firm: ABC Compounding Co., Inc.
Reason for Recall: CGMP Deviations
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Handtastic Foamy Mango Antiseptic Foam Soap Hand & Body Wash, Net Contents : 18oz (532ml), Sold by, Momar Incorporated, 1880 Ellsworth Industrial Drive, N.W., Atlanta, Georgia, 80818.
Lots / Batch Codes & Expiration Dates
1440 bottles
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0111-2027

Theophylline Extended-Release Tablets

Manufacturer / Recalling Firm: Brandywine Pharmaceuticals, LLC
Reason for Recall: CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Theophylline Extended-Release Tablets, 200 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-501-10.
Lots / Batch Codes & Expiration Dates
Lot: 405620, Expiry: 03/31/2028.
Distribution Scope
Nationwide within U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0094-2027

Lynx

Manufacturer / Recalling Firm: ABC Compounding Co., Inc.
Reason for Recall: CGMP Deviations
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lynx, antibacterial hand soap, Refill, Net Contents 1 Gallon, (3.8 L), Manufactured by: ABC Compounding Co., INC., 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808200027.
Lots / Batch Codes & Expiration Dates
2552 bottles
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0090-2027

Delta Foremost Sani-Foam Mango

Manufacturer / Recalling Firm: ABC Compounding Co., Inc.
Reason for Recall: CGMP Deviations
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Delta Foremost Sani-Foam Mango, Net Contents: 1000 ML, 33.8 FL OZ, Manufactured Expressly For: Delta Foremost Chemical Corp., 3915 Air Park Street, Memphis, TN 38118,
Lots / Batch Codes & Expiration Dates
2392 bottles
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0087-2027

Aero Foamy Mango Aloe Vera Antiseptic Hand & Body Wash

Manufacturer / Recalling Firm: ABC Compounding Co., Inc.
Reason for Recall: CGMP Deviations
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Aero Foamy Mango Aloe Vera Antiseptic Hand & Body Wash, Net Contents: 1 Gallon (3.8 L), Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, 30013, UPC 711808198393
Lots / Batch Codes & Expiration Dates
10908 bottles
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0093-2027

Lynx

Manufacturer / Recalling Firm: ABC Compounding Co., Inc.
Reason for Recall: CGMP Deviations
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lynx, antibacterial hand soap, Net Contents 1 Gallon, (3.8 L), Manufactured by: ABC Compounding Co., INC., 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808199925.
Lots / Batch Codes & Expiration Dates
2552 bottles
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0074-2027

ABIRATERONE ACETATE

Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: Labeling: Not Elsewhere Classified
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Abiraterone Acetate Tablets USP 500 mg, 60-count bottles, Rx only, Distributed by: Glenmark Pharmaceuticals USA, Elmwood Park, NJ 07407, NDC 68462-882-60
Lots / Batch Codes & Expiration Dates
Lot #: 13250135, Exp. Date 11/2027
Distribution Scope
Nationwide within the United States
Class III (Low Risk)
Drug recall Recall #: D-0081-2027

ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg

Manufacturer / Recalling Firm: Prodose, Inc.
Reason for Recall: Incorrect label placed on product: Outer carton label correctly identifies drug product in bottle as ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg,but inner label on bottle says ValuHealth Extra Strength Pai...
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg, 40-caplets per bottle, Distributed by:Prodose, Inc. Ronkonkoma, NY 11779, Made in India. UPC 8 50026 88900 0
Lots / Batch Codes & Expiration Dates
Lot #: P260252, Exp 4/30/2029
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0106-2027

OXYTOCIN

Manufacturer / Recalling Firm: Eagle Pharma Outsourcing LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
OXYTOCIN, 30 USP UNITS, Added to 0.9% Sodium Chloride 500 mL - Single-Use Container, Rx Only, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Hoover, AL 35244, UPC: 6985203050. NDC 69852-030-50
Lots / Batch Codes & Expiration Dates
Lot: OXY30-1006, Expiry: 10/10/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0113-2027

ATORVASTATIN CALCIUM

Manufacturer / Recalling Firm: MSN Laboratories Private Limited (Formulations Division, Unit-II)
Reason for Recall: Presence of Foreign Tablets/Capsules
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Atorvastatin Calcium Tablets, USP, 40mg, 1000 tablets per bottle, Rx only, Manufactured by: MSL Laboratories Private Limited, Telangana - 509228, India; Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854-3714. NDC: 72205-024-99
Lots / Batch Codes & Expiration Dates
Lot: DRF09618A, Exp 08-31-2029, DRG02110A, Exp 01-31-2030.
Distribution Scope
Nationwide in the USA.
Class III (Low Risk)
Drug recall Recall #: D-0109-2027

VECURONIUM BROMIDE

Manufacturer / Recalling Firm: Meitheal Pharmaceuticals, Inc
Reason for Recall: Labeling: Label Lacks Warning or Rx Legend
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Vecuronium Bromide for Injection, 20mg, 10 Single-Dose Vials per carton, Sterile, Rx Only, Mfd. for Meitheal Pharmaceuticals, Chicago, IL. NDC: 71288-745-21
Lots / Batch Codes & Expiration Dates
Lot# T1P0113C: Exp. 28-Feb-29 Lot# T1P0612C: Exp. 31-Oct-28
Distribution Scope
US. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0096-2027

People's FM-24 FOAMING High Foaming Antiseptic Hand and Body Wash

Manufacturer / Recalling Firm: ABC Compounding Co., Inc.
Reason for Recall: CGMP Deviations
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
People's FM-24 FOAMING High Foaming Antiseptic Hand and Body Wash, NET CONTENTS: 1000 ML 33.8 FL OZ, Distributed by: People's Janitorial Supply, 955 Main Street, Forest Park, GA 30298, 404-363-2226.
Lots / Batch Codes & Expiration Dates
600 bottles
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0105-2027

PHENYLephrine HCL Infusion

Manufacturer / Recalling Firm: Eagle Pharma Outsourcing LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
PHENYLephrine HCL Infusion, 100 mg per 250 mL in 0.9% Sodium Chloride (0.4 mg/mL), Sterile, Rx Only, Single-Use Container, EAGLE PHARMA OUTSOURCING, 2200 Riverchase Center, Suite 675, Hoover, AL 35244, UPC: 6985210025. NDC 69852-100-25
Lots / Batch Codes & Expiration Dates
Lot: PHENYL100-1004, Expiry: 12/31/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0088-2027

Certus Medical Satin Foam

Manufacturer / Recalling Firm: ABC Compounding Co., Inc.
Reason for Recall: CGMP Deviations
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Certus Medical Satin Foam, 750 ml (25.4 fl. oz.), Manufactured for: Cartus Medical, 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808250930
Lots / Batch Codes & Expiration Dates
28152 bottles
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0085-2027

Palm Antiseptic Hand Soap Net Contents: 1 Gallon

Manufacturer / Recalling Firm: ABC Compounding Co., Inc.
Reason for Recall: CGMP Deviations
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Palm Antiseptic Hand Soap Net Contents: 1 Gallon (3.8 L). Manufactured by: ABC Compounding Co., Inc., 2600 Dogwood Dr., Conyers, GA 30013, UPC 711808196498
Lots / Batch Codes & Expiration Dates
9220 bottles
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0097-2027

PRO CHEM Fresh Start

Manufacturer / Recalling Firm: ABC Compounding Co., Inc.
Reason for Recall: CGMP Deviations
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
PRO CHEM Fresh Start, Antibacterial Hand Soap, Antiseptic Hand Soap, 800mL bag, Sold by: PRO CHEM, Inc.,1475 Bluegrass Lakes Parkway, Alpharetta, GA 30064.
Lots / Batch Codes & Expiration Dates
1944 bottles
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0100-2027

Chemseptic

Manufacturer / Recalling Firm: ABC Compounding Co., Inc.
Reason for Recall: CGMP Deviations
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Chemseptic, Net Contents: 1 Gallon (3.8 L), Distributed By: RMC Rochester Midland Corporation, 155 Paragon Drive, Rochester, NY 14624 USA, Made in USA
Lots / Batch Codes & Expiration Dates
2316 bottles
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0099-2027

Pro Chem Suds Hand Soap

Manufacturer / Recalling Firm: ABC Compounding Co., Inc.
Reason for Recall: CGMP Deviations
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Pro Chem Suds Hand Soap, Net Contents: 18 OZ (532 ml), Sold by Pro Chem Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004
Lots / Batch Codes & Expiration Dates
576 bottles
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0110-2027

Theophylline Extended-Release Tablets

Manufacturer / Recalling Firm: Brandywine Pharmaceuticals, LLC
Reason for Recall: CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle, Distributed by: Brandywine Pharmaceuticals, LLC, West Chester, PA 19382, NDC: 71321-500-10
Lots / Batch Codes & Expiration Dates
Lot: 405617, Expiry: 03/31/2028
Distribution Scope
Nationwide within U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0107-2027

Lidocaine Ointment USP

Manufacturer / Recalling Firm: Direct Rx
Reason for Recall: Subpotent Drug
FDA Report: Nov 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lidocaine Ointment USP, 5.0 % 50g JAR, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534, NDC 72189-0211-50
Lots / Batch Codes & Expiration Dates
LOT#: 03AP2511, 30AP2518, 18JU2519, 18JU2520, Exp. Date 04/30/2027.
Distribution Scope
Nationwide within the United States

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