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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
3 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 581–600 of 1,170 factual FDA recall reports
Class III (Low Risk)
Drug recall Recall #: D-0257-2026

CLINDAMYCIN PHOSPHATE

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
Lots / Batch Codes & Expiration Dates
Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0264-2026

Benadryl

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
Benadryl, 25'S 2PK Box, UPC 815556020316
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-0263-2026

Alka Seltzer

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
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
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-0267-2026

DAYQUIL COLD & FLU

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
DAYQUIL COLD & FLU, 32CT/2PK
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-0276-2026

PEPCID COMPLETE - 25CT

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
PEPCID COMPLETE - 25CT
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-0265-2026

Bayer 2Pk- 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
Bayer 2Pk- 25 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-0259-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Alvogen, Inc
Reason for Recall: Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.
Lots / Batch Codes & Expiration Dates
Lot # MHA21825, Exp Date: December 31, 2027
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0258-2026

TESTO-100 CIII

Manufacturer / Recalling Firm: Advanced Pharmaceutical Technology, Inc.
Reason for Recall: Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
Lots / Batch Codes & Expiration Dates
Lot #: P-22-3, Exp 06-2027
Distribution Scope
GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
Class II (Moderate Risk)
Drug recall Recall #: D-0266-2026

Claritin

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
Claritin, 20 Count, UPC: 655708016305
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-0273-2026

NYQUIL COLD & FLU -32CT/2PK

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
NYQUIL COLD & FLU -32CT/2PK
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-0290-2026

LANREOTIDE ACETATE

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Presence of Particulate Matter.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Lots / Batch Codes & Expiration Dates
Lot, expiry: 4301954IR1 , exp 31/10/2026 ; 4301994IR1 , exp 31/10/2026 ; 4301995IR1 , exp 31/10/2026 ; 4301996IR1 , exp 31/10/2026 ; 4400005IR1 , exp 30/11/2026 ; 4400006IR1 , exp 30/11/2026 ; 4400007IR1 , exp 30/11/2026 ; 4400124IR1 , exp 30/11/2026 ; 4400154IR1 , exp 30/11/2026 ; 4400155IR1 , exp 30/11/2026 ; 4400156IR1 , ex...
Distribution Scope
Nationwide in the USA
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

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