CLASS II Drug recall · Reported 2 Jun 2021 · FDA Enforcement Report

Belbuca (buprenorphine hydrochloride) buccal film 600 mcg recalled

Cardinal Health is recalling Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal, distributed in Florida, Georgia, South Carolina. The recall was initiated on 15 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBL6002004
NDC59385-021, 59385-022, 59385-023, 59385-024, 59385-025, 59385-026
Quantity recalled47 cartons

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0449-2021
FDA event ID
87512
Recalling firm
Cardinal Health, Dublin, OH
Brand
Belbuca
Manufacturer
BioDelivery Sciences International Inc
Classification
Class II
Status
Terminated
Recall initiated
15 Mar 2021
FDA classified
24 May 2021
Reported
2 Jun 2021
Type
Voluntary: Firm initiated
Customers notified by
Letter

Timeline

15 Mar 2021Recall initiated by company
24 May 2021Classified by FDA+70 days
2 Jun 2021Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Product as listed by the FDA

Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA

Where it was distributed

FL, GA, SC

FloridaGeorgiaSouth Carolina

Questions about this recall

Why was it recalled?

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Which lots are affected?

BL6002004

Where was it sold?

FL, GA, SC

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 87512

This product is part of a recall event; the main page for the event is Edarbi (azilsartan medoxomil) tablets 80 mg recalled by Cardinal Health.

ReportedClassRecallCompanyReasonWhere
CLASS IIEdarbi (azilsartan medoxomil) tablets 80 mg recalled by Cardinal HealthEdarbiCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIxigduo XR (dapgliflozin/metformin HCl extended-release) recalledXigduoCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIBelbuca (buprenorphine hydrochloride) buccal film 300 mcg recalledBelbucaCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIInfants Aqueous Vitamin D Oral Drops 400 IU/mL recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IINiacin 250mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IINurtec Odt (rimegepant) 75mg 8 Bpk recalled by Cardinal HealthNurtec OdtCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIEzetimibe And Simvastatin Tablets 10-10mg recalled by Cardinal HealthEzetimibe And SimvastatinCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIIron Dietary Supplement recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIIvermectin Tablets USP 3 mg (2 Foil Strips of each) recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIErythromycin Tablets, USP 250mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIProctofoam HC (hydrocortisone acetate recalled by Cardinal HealthProctofoamCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIVaniqa (eflornithine hydrochloride) Cream recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIMiconazole 7 2% 45gm Apl recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IITriamcinolone Acetonide Ointment recalled by Cardinal HealthTriamcinolone AcetonideCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIPromethazine Plain Oral Solution 6.25mg/; ; Rx; Solution recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IITriumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg recalledTriumeqCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IImedroxyprogesterone acetate injectable suspension, USP, 150MG/ML recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IICatapres-tts-2 1X4 recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIOndansetron HCL 4mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIUbrelvy 100mg 10ud Cplt recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIIntrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIMedroxyprogesterone acetate injectable suspension recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIEletriptan Hydrobromide Tablets 20 mg*-dose Tablets recalledEletriptan HydrobromideCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIPregabalin Capsules 300mg recalled by Cardinal HealthPregabalinCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IILeucovorin 15mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIDarifenacin Extended-release Tablets 15 mg recalled by Cardinal HealthDarifenacinCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IISynjardy (empagliflozin and metformin hydrochloride) recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIxigduo XR (dapagliflozin/metformin HCl extended-release) recalledXigduoCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIDexameth Sod Phos recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IITrelegy Ellipta (fluticasone Furoate recalled by Cardinal HealthTrelegy ElliptaCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IILithium Carb 150mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIFenofibrate Capsules, Ups 67mg recalled by Cardinal HealthFenofibrateCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIMethocarbamol 500mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIVitamin D3 25mcg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIMetoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg recalledMetoprolol Tartrate And HydrochlorothiazideCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIMethotrexate Injection, USP 50 mg recalled by Cardinal HealthMethotrexateCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIBrilinta ticagrelar tablets 60 mg recalled by Cardinal HealthBrilintaCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IILotemax SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IINeomycin Sulf Tablets, USP, 500mg recalled by Cardinal HealthNeomycin SulfateCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IISpiriva HandiHaler (tiotropium bromide inhalation powder) recalledSpirivaCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IITylenol Acetaminophen Pain Regular Strength Liquid Gels recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIPravachol 40mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIOrilissa elagolix tablets equivalent to 155.2 mg elagolix recalledOrilissaCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIedarbyclor Azilsartan Medoxomil recalled by Cardinal HealthEdarbyclorCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIBelsomra (suvorexant) tablets contains 10 mg suvorexant recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IISynjardy XR (empagliflozin and metformin) hydrochloride recalledSynjardyCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIVerapamil Hydrochloride Extended-Release Tablets USP 120 mg recalledVerapamil HydrochlorideCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIHaloperidol Tablets 20mg recalled by Cardinal HealthHaloperidolCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIBenicar 40mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIZolpidem Tartrate Sublingual Tablet 3.5 MG Dose recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIJentadueto XR (linagliptin and metformin hydrochloride recalledJentadueto XrCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIFlovent Diskus 100mcg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIAsmanex Twst 220mcg 60inh Pwd recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIAtropine Sulfate Ophthalmic Solution recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IITherapeutic recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIFerrous Sulfate 75 mg (equivalent to 15 mg Iron) recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIDesvenlafaxine Extended-Release Tablets 25 mg recalledDesvenlafaxineCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIHydrocortisone Acet 30mg recalled by Cardinal HealthHydrocortisone AcetateCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIChantix (varenicline) Tablets Starting Pack Contains recalledChantixCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIAcetaZOLAMIDE Tablets, USP 125 mg recalled by Cardinal HealthAcetazolamideCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IICorgard (nadolol tablets, USP) 40 mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IINitrofurantoin Macrocrystals Capsules 25 mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIPhentermine HCL 30mg 100 C4 recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IINadolol Tablets, USP 40 mg recalled by Cardinal HealthNadololCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIEnalapril Maleate Tablets, USP 2.5 mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIMeloxicam Tablets, USP 7.5 mg recalled by Cardinal HealthMeloxicamCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIEnoxaparin Dofium Injrvyion, Upd 150mg/ 10x1ml Single Dose Syringes recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IISteglatro (ertugliflozin) tablets 15 mg recalled by Cardinal HealthSteglatroCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIDibucaine Topical Anesthetic 1% Hemorrhoidal Ointment 28gm recalledDibucaine Topical Anesthetic 1% HemorrhoidalCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIVimpat(lacosamide) Tablets ,100 mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IINarcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box recalledNarcanCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IITrelegy Ellipta (fluticasone furoate, umeclidinium recalledTrelegy ElliptaCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIAuryxia (ferric citrate) tablets 210 mg* recalled by Cardinal HealthAuryxiaCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIBenztropine Mesylate Tablets, USP in all pack sizes recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IILevalbuterol tartrate HFA Inhalation Aerosol recalled by Cardinal HealthLevalbuterol Tartrate Hfa InhalationCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IISulindac Tablets, USP, 200mg recalled by Cardinal HealthSulindacCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIVitamin D3 25mcg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIRectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only recalledRectivCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIInvega Sustenna 156mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IILamotrigine Extended-Release Tablets 250 mg recalled by Cardinal HealthLamotrigine Extended ReleaseCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IINorvir Ritonavir Tablets 100 mg recalled by Cardinal HealthNorvirCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIChantix (varenicline) Tablets Continuing Month Box Contains recalledChantixCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IISodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIArnuity Ellipta (fluticasone furoate inhalation powder) recalledArnuity ElliptaCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIIbuprofen Oral Suspension USP 100mg recalled by Cardinal HealthIbuprofenCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IISiladryl Sf Af recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIHydrocortisone Ointment USP 1% Maximum Strength recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IICyanocobal Injection 1000MCG/ML 25X1ML recalled by Cardinal HealthCyanocobalaminCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IITirosint(levothyroxine sodium) capsules 175MCG recalledTirosintCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIBenzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel recalledBenzoyl PeroxideCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IINat B Vit D3 2000u recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIRestasis 0.05%. Opth Pf recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIChildren's Loratadine Oral Solution USP, 5 mg recalledChildrens LoratadineCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIBanzel (rufinamide) tablets 200 mg recalled by Cardinal HealthBanzelCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIPhentermine HCL 37.5mg 100 C4 recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIPolyethylene Glycol 3350 Powder for Solution, Laxative recalledPolyethylene Glycol 3350Cardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIVitamin D3 Cholecalciferol 50,000 IU Dietary Supplement recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIOfloxacin 0.3% Opth recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIColcrys (colchicine, USP) tablets 0.6 mg recalled by Cardinal HealthCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC
CLASS IIVitamin D3 Cholecalciferol 50,000 IU Dietary Supplement recalledCardinal HealthManufacturing (CGMP) DeviationsFL, GA, SC

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All 22
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