<?xml version="1.0"?>
<ownershipDocument>

    <schemaVersion>X0303</schemaVersion>

    <documentType>4</documentType>

    <periodOfReport>2009-02-11</periodOfReport>

    <notSubjectToSection16>0</notSubjectToSection16>

    <issuer>
        <issuerCik>0000812796</issuerCik>
        <issuerName>DOR BIOPHARMA INC</issuerName>
        <issuerTradingSymbol>DORB</issuerTradingSymbol>
    </issuer>

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0001092601</rptOwnerCik>
            <rptOwnerName>SIGMA TAU FINANZIARIA SPA</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <rptOwnerStreet1>VIA SUDAFRICA, 20</rptOwnerStreet1>
            <rptOwnerStreet2></rptOwnerStreet2>
            <rptOwnerCity>ROME</rptOwnerCity>
            <rptOwnerState>L6</rptOwnerState>
            <rptOwnerZipCode>00144</rptOwnerZipCode>
            <rptOwnerStateDescription>ITALY</rptOwnerStateDescription>
        </reportingOwnerAddress>
        <reportingOwnerRelationship>
            <isDirector>0</isDirector>
            <isOfficer>0</isOfficer>
            <isTenPercentOwner>1</isTenPercentOwner>
            <isOther>0</isOther>
            <officerTitle></officerTitle>
            <otherText></otherText>
        </reportingOwnerRelationship>
    </reportingOwner>

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0001170881</rptOwnerCik>
            <rptOwnerName>SIGMA TAU INTERNATIONAL SA</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <rptOwnerStreet1>19-21 BLVD. DU PRINCE HENRI</rptOwnerStreet1>
            <rptOwnerStreet2></rptOwnerStreet2>
            <rptOwnerCity></rptOwnerCity>
            <rptOwnerState>N4</rptOwnerState>
            <rptOwnerZipCode>L-1724</rptOwnerZipCode>
            <rptOwnerStateDescription>LUXEMBOURG</rptOwnerStateDescription>
        </reportingOwnerAddress>
        <reportingOwnerRelationship>
            <isDirector>0</isDirector>
            <isOfficer>0</isOfficer>
            <isTenPercentOwner>1</isTenPercentOwner>
            <isOther>0</isOther>
            <officerTitle></officerTitle>
            <otherText></otherText>
        </reportingOwnerRelationship>
    </reportingOwner>

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0001385930</rptOwnerCik>
            <rptOwnerName>Sigma-Tau America S.A.</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <rptOwnerStreet1>19-21 BLVD. DU PRINCE HENRI</rptOwnerStreet1>
            <rptOwnerStreet2></rptOwnerStreet2>
            <rptOwnerCity></rptOwnerCity>
            <rptOwnerState>N4</rptOwnerState>
            <rptOwnerZipCode>L-1724</rptOwnerZipCode>
            <rptOwnerStateDescription>LUXEMBOURG</rptOwnerStateDescription>
        </reportingOwnerAddress>
        <reportingOwnerRelationship>
            <isDirector>0</isDirector>
            <isOfficer>0</isOfficer>
            <isTenPercentOwner>1</isTenPercentOwner>
            <isOther>0</isOther>
            <officerTitle></officerTitle>
            <otherText></otherText>
        </reportingOwnerRelationship>
    </reportingOwner>

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0001385625</rptOwnerCik>
            <rptOwnerName>Sigma-Tau Pharmaceuticals, Inc.</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <rptOwnerStreet1>9841 WASHINGTONIAN BLVD</rptOwnerStreet1>
            <rptOwnerStreet2>SUITE 500</rptOwnerStreet2>
            <rptOwnerCity>GAITHERSBURG</rptOwnerCity>
            <rptOwnerState>MD</rptOwnerState>
            <rptOwnerZipCode>20878</rptOwnerZipCode>
            <rptOwnerStateDescription></rptOwnerStateDescription>
        </reportingOwnerAddress>
        <reportingOwnerRelationship>
            <isDirector>0</isDirector>
            <isOfficer>0</isOfficer>
            <isTenPercentOwner>1</isTenPercentOwner>
            <isOther>0</isOther>
            <officerTitle></officerTitle>
            <otherText></otherText>
        </reportingOwnerRelationship>
    </reportingOwner>

    <nonDerivativeTable>
        <nonDerivativeTransaction>
            <securityTitle>
                <value>Common Stock</value>
            </securityTitle>
            <transactionDate>
                <value>2009-02-11</value>
            </transactionDate>
            <deemedExecutionDate></deemedExecutionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>P</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
            </transactionCoding>
            <transactionTimeliness>
                <value></value>
            </transactionTimeliness>
            <transactionAmounts>
                <transactionShares>
                    <value>25000000</value>
                </transactionShares>
                <transactionPricePerShare>
                    <value>0.18</value>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>A</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>41666667</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>I</value>
                    <footnoteId id="F1"/>
                </directOrIndirectOwnership>
                <natureOfOwnership>
                    <value>Indirect</value>
                    <footnoteId id="F1"/>
                </natureOfOwnership>
            </ownershipNature>
        </nonDerivativeTransaction>
    </nonDerivativeTable>

    <derivativeTable></derivativeTable>

    <footnotes>
        <footnote id="F1">Shares directly owned by Sigma-Tau Pharmaceuticals, Inc. (?Pharmaceuticals?).  Pharmaceuticals is a direct wholly-owned subsidiary of Sigma-Tau America S.A. (?America?).  America is a direct wholly-owned subsidiary of Sigma-Tau International S.A. (?International?).  International is a direct wholly-owned subsidiary of Sigma-Tau Finanziaria S.p.A.</footnote>
    </footnotes>

    <remarks>Exhibit List

Exhibit 99 - Joint Filer Information</remarks>

    <ownerSignature>
        <signatureName>/s/ Maurizio Terenzi, Proxy-holder authorized</signatureName>
        <signatureDate>2009-02-13</signatureDate>
    </ownerSignature>
</ownershipDocument>
