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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 461–480 of 999 factual FDA recall reports
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
Class II (Moderate Risk)
Drug recall Recall #: D-0232-2026

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
Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.
Lots / Batch Codes & Expiration Dates
Lot: D05159H, expires: 07-31-2027
Distribution Scope
U.S.A. Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0238-2026

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, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.
Lots / Batch Codes & Expiration Dates
Lot#: A250043, EXP Date 06/30/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0240-2026

Ciclopirox Shampoo

Manufacturer / Recalling Firm: SUN PHARMA /TARO
Reason for Recall: Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
Lots / Batch Codes & Expiration Dates
Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0235-2026

BACLOFEN

Manufacturer / Recalling Firm: Golden State Medical Supply Inc.
Reason for Recall: Presence of Foreign Tablets/Capsules
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10
Lots / Batch Codes & Expiration Dates
Lot GS065762
Distribution Scope
Nationwide within the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0221-2026

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution

Manufacturer / Recalling Firm: Fagron Compounding Services
Reason for Recall: Incorrect Product Formulation
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
Lots / Batch Codes & Expiration Dates
Lot#: C274-000047958; Exp. December 19, 2025
Distribution Scope
U.S. Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0222-2026

NEBIVOLOL

Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: Cross Contamination with Other Products
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.
Lots / Batch Codes & Expiration Dates
Lot# 17240988; Exp. 05/31/2026
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0225-2026

CINACALCET

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
Lots / Batch Codes & Expiration Dates
Lot 5PB0164, exp 1/31/2027
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0218-2026

LANTHANUM CARBONATE

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Failed stability specifications: Out of specification for hardness test
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.
Lots / Batch Codes & Expiration Dates
Lot# NB240314, exp 12/31/2025
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0224-2026

CINACALCET

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0226-2026

CINACALCET

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
Lots / Batch Codes & Expiration Dates
Lot 5PB0183, exp 1/31/2027
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0227-2026

SERTRALINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: Defective container - seal not adhering to bottles
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Lots / Batch Codes & Expiration Dates
Lot # QB00865, exp. date Feb 2028
Distribution Scope
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