CLASS II Drug recall · Reported 1 Feb 2023 · FDA Enforcement Report

Dexamethasone 16mg/ML Vial) Injectable recalled by Pharmacy Innovations

Pharmacy Innovations is recalling Dexamethasone 16mg/ML Vial) Injectable, distributed nationwide in the US. The recall was initiated on 22 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codest20221116@36 t20221117@11 t20221108@87
Quantity recalledN/A

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-0201-2023
FDA event ID
91332
Recalling firm
Pharmacy Innovations, Erie, PA
Classification
Class II
Status
Terminated
Recall initiated
22 Dec 2022
FDA classified
26 Jan 2023
Reported
1 Feb 2023
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Sterility

Timeline

22 Dec 2022Recall initiated by company
26 Jan 2023Classified by FDA+35 days
1 Feb 2023Published in enforcement report+6 days

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

Reason for recall

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE; DEXAMETHASONE-PF- 0.1% (1ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Which lots are affected?

t20221116@36 t20221117@11 t20221108@87

Where was it sold?

Nationwide in the USA

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

58 other products · FDA event 91332

This product is part of a recall event; the main page for the event is Glutathione L Reduced 100mg/ML Nebvl) Inhalation recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIGlutathione L Reduced 100mg/ML Nebvl) Inhalation recalledPharmacy InnovationsSterilityNationwide
CLASS IIMethion/inosit/choline/cyanocobal 25mg/50mg/50mg/1mg/ML recalledPharmacy InnovationsSterilityNationwide
CLASS IIAtropine sulfate 0.05% dropper, and Atropine sulfate 0.01% dropper recalledPharmacy InnovationsSterilityNationwide
CLASS IITobramycin Fortified 15mg/ML Oph Solution recalledPharmacy InnovationsSterilityNationwide
CLASS IIAcetylcysteine 10% Ophthalmic Solution recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IIPe1/papav/phen 20mcg/30mg/2mg/ML Vial) Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIVancomycin Fortified 10mg/ML Droptainer) Oph Solution recalledPharmacy InnovationsSterilityNationwide
CLASS IITacrolimus 0.03% Oph Solution Tacrolimus 0.1% Droptainer) recalledPharmacy InnovationsSterilityNationwide
CLASS IIPhenol 10% Vial) Injectable recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IIGentamicin Bladder 0.08mg/ML Syringe) Irrigation recalledPharmacy InnovationsSterilityNationwide
CLASS IIThiamine/ribofla/niacinami/dexpanth/pyridox/hydroxycobal recalledPharmacy InnovationsSterilityNationwide
CLASS IIPapaverine/phentolamine 30mg/0.5mg/ML Vial) Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIScopolamine Hydrobromide 0.25% Oph Solution recalledPharmacy InnovationsSterilityNationwide
CLASS IIPe1/papav/atrop/chloprom** 7mcg/8.7mg/0.1mg/1.8mg/ML Vial) recalledPharmacy InnovationsSterilityNationwide
CLASS IIBSS Plus/Lidocaine Opth 1% syringe) Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIPolyhexamethylene Biguanide 0.2mg/ML recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IIEstradiol 0.05% OPH Solution recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IIVoriconazole 10mg/ML Dropper) Oph Solution recalledPharmacy InnovationsSterilityNationwide
CLASS IIEstradiol Cyp/test Cyp- Ss Oil- 2mg/50mg/ML Vial) Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIApomorphine HCL 2MG/ML vial) Injectable recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IITestosterone 3% (4gm Tube) Ophth Ointme Testosterone recalledPharmacy InnovationsSterilityNationwide
CLASS IICeftazidime Intravitreal vial) 22.5 MG/ML(2.25MG/ Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IICholecalciferol (Vitamin D3) 100,000U/ML Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIEdetate Calcium Disodium 400MG/ML vial) Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIKetamine 50mg/ML Vial) Injectable recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IIMinoxidil 0.75% vial) Injectable recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IIBuprenorphine HCL 0.9 MG/ML vial) Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIClindamycin/EDTA Calcium 4.1667MG/0.333MG/ML syringe) Irrigation recalledPharmacy InnovationsSterilityNationwide
CLASS IINadh 10mg/ML Vial) Injectable recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IISemaglutide 0.5mg/ML Vial) Injectable Semaglutide 1mg/ML recalledPharmacy InnovationsSterilityNationwide
CLASS IICyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine recalledPharmacy InnovationsSterilityNationwide
CLASS IIMethylcobalamin 12.5mg/ML Vial) Injectable Methylcobalamin recalledPharmacy InnovationsSterilityNationwide
CLASS IIProgesterone-gs Oil- 100mg/ML Vial) Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIHydroxocobalamin-pf- 1mg/ML Vial) Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIProstaglandin (pe1) 45mcg Vial) Injectable Prostaglandin E1 recalledPharmacy InnovationsSterilityNationwide
CLASS IIPolidocanol 50mg/ML (5%) Vial) Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIAlbuterol (PF/Sulfuric Acid/Dye Free) - tube recalledPharmacy InnovationsSterilityNationwide
CLASS IIDexpanthenol/Pyridoxine/Hydroxocobalamin-PF recalledPharmacy InnovationsSterilityNationwide
CLASS IILevemir-sts- 100u/ML Vial) Injectable recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IIMethylcobalamin 1MG/ML vial) recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IIDutasteride 0.1% VIAL) Injectable recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IIFlurbiprofen -corn Oil- 0.04% Droptainer) Oph Solution recalledPharmacy InnovationsSterilityNationwide
CLASS IIMitomycin 0.4mg/ML Droptainer) Oph Solution recalledPharmacy InnovationsSterilityNationwide
CLASS IIVitamin D3-aqueous- 10,000iu/ML Vial) Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIHydroxocobalamin 25MG/ML vial) Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIEdetate Disodium (Vet) 1% droptainer) Oph Solution recalledPharmacy InnovationsSterilityNationwide
CLASS IIGlycerin 72% (w/v) Vial) Injectable recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IIMitomycin 0.2mg/ML Droptainer) Oph Solution recalledPharmacy InnovationsSterilityNationwide
CLASS IIMethotrexate Intravitreal Vial) 4mg/ML (400mcg/ Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIHeparin/lido HCL/sodium Bicarb 100u/2mg/16.8mg/ML Syringe) recalledPharmacy InnovationsSterilityNationwide
CLASS IIGlycerin/lidocaine HCL/epinephrine 31%(v/v)/0.17%/0.00017% Vials) recalledPharmacy InnovationsSterilityNationwide
CLASS IIMagnesium Chloride Hexahydrate-pf- 200mg/ML Vial) Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS II5-Fluorouracil 1% droptainer, and droptainer Ophthalmic recalledPharmacy InnovationsSterilityNationwide
CLASS IIChlorpheniramine/Hyoscyamine 10MG/0.25MG/ML Injectable recalledPharmacy InnovationsSterilityNationwide
CLASS IIEthyl Alcohol 95% vial) Injectable recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IILidocaine-pf- 5% Vial) Injectable recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
CLASS IIPhosphatidylcholine/deoxycholic Acid Vial) 50mg/50mg/ML recalledPharmacy InnovationsSterilityNationwide
CLASS IIGlycerin Sterile 99% Vial and Vial, Injectable recalledPharmacy InnovationsSterilityNationwide

More recalls from Pharmacy Innovations

All 59
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIGlycerin Sterile 99% Vial and Vial, Injectable recalledPharmacy InnovationsSterilityNationwide
DrugCLASS IIPhosphatidylcholine/deoxycholic Acid Vial) 50mg/50mg/ML recalledPharmacy InnovationsSterilityNationwide
DrugCLASS IILidocaine-pf- 5% Vial) Injectable recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
DrugCLASS IIEthyl Alcohol 95% vial) Injectable recalled by Pharmacy InnovationsPharmacy InnovationsSterilityNationwide
DrugCLASS IIChlorpheniramine/Hyoscyamine 10MG/0.25MG/ML Injectable recalledPharmacy InnovationsSterilityNationwide

Other Dexamethasone recalls

All 33
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIDexamethasone Sodium Phosphate Injection, USP, 100 mg recalledDexamethasone Sodium PhosphateSomerset TherapeuticsPotency & AssayNationwide
DrugCLASS IIDexamethasone Sodium Phosphate injection USP, 120mg recalled by Eugia USDexamethasone Sodium PhosphateEugia USPotency & AssayNationwide
DrugCLASS IIDexamethasone Elixir, USP 0.5 mg/, Net recalledMorton Grove PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIDexamethasone sodium phosphate, sterile otic solution recalledEdge PharmaSterilityNationwide
DrugCLASS IIDexamethasone (LA) Injectable Suspension recalledFusion IV PharmaceuticalsSterilityNationwide