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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 621–640 of 1,170 factual FDA recall reports
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
Class II (Moderate Risk)
Drug recall Recall #: D-0229-2026

LIDOCAINE

Manufacturer / Recalling Firm: Novocol Pharmaceutical of Canada, Inc.
Reason for Recall: Defective container: cracked/broken cartridges
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.
Lots / Batch Codes & Expiration Dates
Lot: D05362A, expires: 07-31-2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0233-2026

CARBOCAINE

Manufacturer / Recalling Firm: Novocol Pharmaceutical of Canada, Inc.
Reason for Recall: Defective container: cracked/broken cartridges
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05.
Lots / Batch Codes & Expiration Dates
Lot: D05159I, expires: 07-31-2027
Distribution Scope
U.S.A. Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0236-2026

CISATRACURIUM BESYLATE

Manufacturer / Recalling Firm: SOMERSET THERAPEUTICS LLC
Reason for Recall: Subpotent product:out of specification assay results observed during long term stability testing.
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.
Lots / Batch Codes & Expiration Dates
Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0234-2026

ORAVERSE

Manufacturer / Recalling Firm: Novocol Pharmaceutical of Canada, Inc.
Reason for Recall: Defective container: cracked/broken cartridges
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10
Lots / Batch Codes & Expiration Dates
Lot: D05004E, expires: 04-30-2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0228-2026

XYLOCAINE

Manufacturer / Recalling Firm: Novocol Pharmaceutical of Canada, Inc.
Reason for Recall: Defective container: cracked/broken cartridges
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.
Lots / Batch Codes & Expiration Dates
Lot: D05337B, expires: 06-30-2027
Distribution Scope
U.S.A. Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0237-2026

CISATRACURIUM BESYLATE

Manufacturer / Recalling Firm: SOMERSET THERAPEUTICS LLC
Reason for Recall: Subpotent product:out of specification assay results observed during long term stability testing.
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.
Lots / Batch Codes & Expiration Dates
Lot #: A250020, Exp Date 06/30/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0230-2026

POLOCAINE

Manufacturer / Recalling Firm: Novocol Pharmaceutical of Canada, Inc.
Reason for Recall: Defective container: cracked/broken cartridges
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.
Lots / Batch Codes & Expiration Dates
Lot: D05159C, expires: 07-31-2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0231-2026

MEPIVACAINE

Manufacturer / Recalling Firm: Novocol Pharmaceutical of Canada, Inc.
Reason for Recall: Defective container: cracked/broken cartridges
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.
Lots / Batch Codes & Expiration Dates
Lot: D05159G, expires: 07-31-2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0239-2026

Ondansetron ODT Tablets

Manufacturer / Recalling Firm: Preferred Pharmaceuticals, Inc.
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: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01
Lots / Batch Codes & Expiration Dates
Lot: J1325J, I1725P, EXP Date: 4/30/2027.
Distribution Scope
Natinowide 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