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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 421–440 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0272-2026

LIQUID NYQUIL a) regular

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0260-2026

AQ 120 GFEW

Manufacturer / Recalling Firm: Encon Safety Products Co
Reason for Recall: cGMP deviations.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
Lots / Batch Codes & Expiration Dates
Lot #: 239066, Exp. Date 1/24/2027; 378106, Exp. Date 3/8/2026; 379202, Exp. Date 3/29/2026; 379750, Exp. Date 4/24/2026; 380983, Exp. Date 5/24/2026; 382901, Exp. Date 7/11/2026; 384682, Exp. Date 8/16/2026; 386189, Exp. Date 9/20/2026; 387559, Exp. Date 10/11/2026; 388381, Exp. Date 11/2/2026; 398066, Exp. Date 1/24/2027; 389477, Exp. Date 2/21/2...
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0282-2026

Carmex a) jar

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0275-2026

PEPTO BISMOL 32CT

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
PEPTO BISMOL 32CT
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0261-2026

Advil a) Ibuprofen

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0278-2026

Halls Cough Drops a) BAGS

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0274-2026

CHILDREN NYQUIL

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0286-2026

Deodorant: a) Axe

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY DEODORANT, CHERRY BLOSSOSM, 24CT, 1.8oz, UPC: 048155921092; e) AXE, BODY SPRAY, APOLLO, 6CT, 150ML; f) AXE, BODY SPRAY, BLACK, 6CT, 150ML; g) AXE, BODY SPRAY, DARK TEMPTATION, 6CT, 150ML; h) AXE, BODY SPRAY, GOLD, 6CT, 150ML; i) AXE, BODY SPRAY, EXCITE, 6CT, 150ML; j) AXE, BODY SPRAY, ICE CHILL, 6CT, 150ML; k) AXE, BODY SPRAY, MUSK, 6CT, 150ML; l) AXE, DEODORANT SPRAY, ADRENALIN, 6CT, 150ML
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0256-2026

FLUOCINOLONE ACETONIDE

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
Lots / Batch Codes & Expiration Dates
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Distribution Scope
Nationwide within the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0287-2026

Toothpaste: a) COLGATE

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609; COLGATE, MAXFRESH, SPICY FRESH, RED TOOTH PASTE, 72CT, 150G; e) CREST, TOOTHPASTE, 40CT, 8.2OZ, UPC: 037000247081
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0269-2026

EXCEDRIN 2'S DISP.- 30 CT

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
EXCEDRIN 2'S DISP.- 30 CT
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0281-2026

Personal Care

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0284-2026

LUCKY ICE

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0271-2026

MOTRIN 2'S DISP.- 50CT

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
MOTRIN 2'S DISP.- 50CT
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0279-2026

TUMS a) Assorted

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0262-2026

Aleve 1's

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Aleve 1's, 60 CT
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0285-2026

Petroleum jelly: a) Vaseline Petroleum Jelly

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0283-2026

Personal Care

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0280-2026

Swan

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Swan, White Clear Alcohol, 50%, 16oz, 12 count
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0270-2026

EXCEDRIN MIGRAINE 2'S- 25 CT

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
EXCEDRIN MIGRAINE 2'S- 25 CT
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US 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