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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 601–620 of 1,170 factual FDA recall reports
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.
Class II (Moderate Risk)
Drug recall Recall #: D-0268-2026

LIQUID DAYQUIL 12/8oz

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 DAYQUIL 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-0277-2026

TYLENOL a) 500 MG.

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
TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 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-0249-2026

Dexamethasone Moxifloxacin

Manufacturer / Recalling Firm: Imprimis NJOF, LLC
Reason for Recall: Presence of particulate matter - Glass like particles.
FDA Report: Jan 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1
Lots / Batch Codes & Expiration Dates
Lot: 25MAY051, Expires: 06/26/2026; 25AUG003, Expires:08/07/2026
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0250-2026

Dexamethasone Moxifloxacin Ketorolac

Manufacturer / Recalling Firm: Imprimis NJOF, LLC
Reason for Recall: Presence of particulate matter - Glass like particles.
FDA Report: Jan 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.
Lots / Batch Codes & Expiration Dates
Lot: 25APR001A, 25APR001B, Expires: 04/03/2026.
Distribution Scope
U.S Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0248-2026

FESOTERODINE FUMARATE

Manufacturer / Recalling Firm: Alembic Pharmaceuticals Limited
Reason for Recall: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
FDA Report: Jan 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
Lots / Batch Codes & Expiration Dates
Lot# 2405003360, Exp Date: Jan 31, 2026
Distribution Scope
US Nationwide and PR.
Class II (Moderate Risk)
Drug recall Recall #: D-0292-2026

ROSUVASTATIN

Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Out of specification for dissolution.
FDA Report: Jan 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
Lots / Batch Codes & Expiration Dates
Lot #49124, Exp Date 12/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0253-2026

ORL Kids Natural Toothpaste

Manufacturer / Recalling Firm: Signature Formulations, LLC
Reason for Recall: cGMP Deviations
FDA Report: Jan 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
Lots / Batch Codes & Expiration Dates
Lot #: 250520P4, Exp. Date 05/27
Distribution Scope
AZ only
Class II (Moderate Risk)
Drug recall Recall #: D-0255-2026

OXYCODONE AND ACETAMINOPHEN

Manufacturer / Recalling Firm: SpecGx, LLC
Reason for Recall: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
FDA Report: Jan 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
Lots / Batch Codes & Expiration Dates
Lot: 0522J23493, expires: 03/2027.
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0252-2026

ORL Kids Mouthwash

Manufacturer / Recalling Firm: Signature Formulations, LLC
Reason for Recall: cGMP Deviations
FDA Report: Jan 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Lots / Batch Codes & Expiration Dates
Lot #: 250505P9, Exp. Date 05/27
Distribution Scope
AZ only

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