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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 441–460 of 999 factual FDA recall reports
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
Class I (High Risk)
Drug recall Recall #: D-0288-2026

REBOOST

Manufacturer / Recalling Firm: Medinatura New Mexico, inc.
Reason for Recall: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
FDA Report: Jan 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0251-2026

Tri-Moxi+¿

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
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.
Lots / Batch Codes & Expiration Dates
Lot: 25JAN033A, 25JAN033B, Expires: 02/12/2026.
Distribution Scope
U.S Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0254-2026

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, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Lots / Batch Codes & Expiration Dates
Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
Distribution Scope
Nationwide
Class I (High Risk)
Drug recall Recall #: D-0289-2026

CLEARLIFE EXTRA STRENGTH

Manufacturer / Recalling Firm: Medinatura New Mexico, inc.
Reason for Recall: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
FDA Report: Jan 14, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887
Lots / Batch Codes & Expiration Dates
All lots within expiry.
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0243-2026

CHLORAPREP SWABSTICK

Manufacturer / Recalling Firm: CareFusion 213, LLC
Reason for Recall: Lack of Assurance of Sterlity
FDA Report: Jan 07, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29
Lots / Batch Codes & Expiration Dates
Lot #: 5086623, Exp. Date 03/31/2028
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0244-2026

Wegovy

Manufacturer / Recalling Firm: Novo Nordisk Inc.
Reason for Recall: Presence of Particulate Matter: Hair was found in a prefilled syringe
FDA Report: Jan 07, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14
Lots / Batch Codes & Expiration Dates
Lot #: RZFHD52, RZFHW93; Exp Date 10/31/2026
Distribution Scope
Nationwide within the United States.
Class II (Moderate Risk)
Drug recall Recall #: D-0245-2026

Wegovy

Manufacturer / Recalling Firm: Novo Nordisk Inc.
Reason for Recall: Presence of Particulate Matter: Hair was found in a prefilled syringe
FDA Report: Jan 07, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14
Lots / Batch Codes & Expiration Dates
Lot #: RZFYK06, RZFYA53; Exp Date 3/31/2027
Distribution Scope
Nationwide within the United States.
Class II (Moderate Risk)
Drug recall Recall #: D-0246-2026

ONDANSETRON

Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished produ...
FDA Report: Jan 07, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
Lots / Batch Codes & Expiration Dates
Lot #: 19251311, Exp Date April 2027
Distribution Scope
Nationwide within the United States
Class III (Low Risk)
Drug recall Recall #: D-0247-2026

TRAZODONE HYDROCHLORIDE

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
FDA Report: Jan 07, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
Lots / Batch Codes & Expiration Dates
Lot # EA00237A, Exp Date: 04/30/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0242-2026

NOXAFIL

Manufacturer / Recalling Firm: Merck Sharp & Dohme LLC
Reason for Recall: Presence of particulate matter: potential presence of metal particulates in the product.
FDA Report: Dec 31, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02.
Lots / Batch Codes & Expiration Dates
Lot#: Z012339, Z010344, Z009908, Z009909, Exp Date 12-31-2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0241-2026

EMEND

Manufacturer / Recalling Firm: Merck Sharp & Dohme LLC
Reason for Recall: Presence of particulate matter: potential presence of metal particulates in the product.
FDA Report: Dec 31, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Limited Athlone, Ireland, NDC 0006-3066-03
Lots / Batch Codes & Expiration Dates
Lot #: Z014503, Exp 11/15/2027
Distribution Scope
Nationwide in 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