CLASS II Drug recall · Reported 25 Nov 2015 · FDA Enforcement Report

Pyridoxine Injection, 100 mg/mL vial recalled by Downing Labs

Downing Labs is recalling Pyridoxine Injection, 100 mg/mL vial, distributed nationwide in the US. The recall was initiated on 16 Oct 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots
Quantity recalled280 vials

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-0373-2016
FDA event ID
72455
Recalling firm
Downing Labs, Dallas, TX
Classification
Class II
Status
Terminated
Recall initiated
16 Oct 2015
FDA classified
18 Nov 2015
Reported
25 Nov 2015
Type
Voluntary: Firm initiated
Customers notified by
Press Release
Reason category
Sterility

Timeline

16 Oct 2015Recall initiated by company
18 Nov 2015Classified by FDA+33 days
25 Nov 2015Published in enforcement report+7 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

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

Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

Where it was distributed

Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

All lots

Where was it sold?

Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

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

47 other products · FDA event 72455

This product is part of a recall event; the main page for the event is L-Tryptophan Injectable, 30mg/mL vial recalled by Downing Labs.

ReportedClassRecallCompanyReasonWhere
CLASS IIL-Tryptophan Injectable, 30mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIAcetyl-L-Carnitine Injectable, 100mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIMagnesium Sulfate 50% Injectable vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIGlucosamine HCL Injectable, 200mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IISermorelin/Ghrp-6/Ghrp-2 Injection 3MG/3MG/3MG vial recalledDowning LabsSterilityNationwide
CLASS IIProcaine Injectables 20mg/mL and 2% vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIB12 Injection 12.5/12.5MG recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IITestosterone Cypionate Injection (Sesame Oil), 200mg/mL vial recalledDowning LabsSterilityNationwide
CLASS IIFolic Acid Injection, 10mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIMIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL vial recalledDowning LabsSterilityNationwide
CLASS IIRiboflavin-5-Phosphate Injectable,10mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IITnprdc Injection vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIDMPS Injectable, 50mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIMethylcobalamin Buffered Injectable, 5mg/mL vial recalledDowning LabsSterilityNationwide
CLASS IITaurine Injectable, 50mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIThiotic Acid Injection, 25mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIL-Glutathione Injection, 200mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIHCG (Lyophilized) Injectable vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIL-Arginine Injection, 100mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIMethylcobalamin Injection Buffered 5mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIPhosphatidylcholine/Deoxycholic Acid Injection (Preserved) 10/4.75% recalledDowning LabsSterilityNationwide
CLASS IIDMSO 99% Injection vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIThiamine HCl Injection, 100mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIMicml Trndppc Injection (Preserved) vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIGreen Tea (EGCG) Injectable, 10mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIDMAE Dimethylaminoethanol Injection, 100mg/mL vial recalledDowning LabsSterilityNationwide
CLASS IICo-Enzyme Q-10 Injectable, 20mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIPotassium Chloride Injection (20mEq/, 2mEq/ML vial recalledDowning LabsSterilityNationwide
CLASS IITnpdr Injection Buffered vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIMagnesium Sulfate Injectable, 14.28% vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIEDTA Disodium Injectable, 150mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIZinc Sulfate (Elemental) Injection, 10mg/mL vial recalledDowning LabsSterilityNationwide
CLASS IIMagnesium Sulfate Injection (4060mOsm/L), 50% vial recalledDowning LabsSterilityNationwide
CLASS IIEDTA Calcium Disodium Injectable, 300mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIPiracetam Injection, 200mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIL-Glutamine Injectable, 30mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIMethylcobalamin Buffered Injectable, 1mg/mL recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIMagnesium Chloride Hexahydrate Injection 200mg/mL vial recalledDowning LabsSterilityNationwide
CLASS IIL-Tyrosine Injectable, 25mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIHydroxocobalamin Injection (Buffered) 1mg/mL vial recalledDowning LabsSterilityNationwide
CLASS IIVitamin D3 Injectable, 10,000 U/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIAscorbic Acid Injectable 500mg/mL recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IICalcium Gluconate (680mOsm/L) Injection 10% vial recalledDowning LabsSterilityNationwide
CLASS IIM.I.C Injection (Preserved), 25/50/25mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIDexpanthenol Injection, 250mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IICyanocobalamin Buffered Injectable 3mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
CLASS IIChromium Injectable, 200mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide

More recalls from Downing Labs

All 48
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIChromium Injectable, 200mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
DrugCLASS IICyanocobalamin Buffered Injectable 3mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
DrugCLASS IIDexpanthenol Injection, 250mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
DrugCLASS IIM.I.C Injection (Preserved), 25/50/25mg/mL vial recalled by Downing LabsDowning LabsSterilityNationwide
DrugCLASS IICalcium Gluconate (680mOsm/L) Injection 10% vial recalledDowning LabsSterilityNationwide

Other Pyridoxine recalls

All 23
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIPyridoxine 100 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
DrugCLASS IIPyridoxine HCL 100 mg/mL, Multi-Dose vial recalledOlympia Compounding PharmacySterilityNationwide
DrugCLASS IIPyridoxine Hydrochloride Injection recalled by Fusion IV PharmaceuticalsFusion IV PharmaceuticalsSterilityNationwide
DrugCLASS IIPyridoxine HCl, 100 mg/mL Injection vial recalled by Promise PharmacyPromise PharmacySterilityNationwide
DrugCLASS IIPyridoxine 100 mg/mL MDV Injectable, Pharm D Solutions recalledPharm D SolutionsSterilityNationwide