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Drug Recalls

Last updated

Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.

3 Class I (most serious) drug recalls reported in the last 30 days.

3,250 recalls

  • Class II Ongoing

    Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding · Pentosan Polysulfate Sodium

    Lots, distribution and details
    Product
    Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding
    Lots / codes
    Batch#: 11292109A2, Exp 5/28/2022, 01242202A1, Exp 6/18/2022; 03022214A1, Exp 8/29/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    220 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1221-2022
  • Class II Ongoing

    Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Product
    Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
    Lots / codes
    Batch#: a) 10272107A1, Exp 4/25/2022; 12072130A1, Exp 6/5/2022; b) 01032230A1, Exp 7/2/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    243 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1220-2022
  • Class II Ongoing

    NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Product
    NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
    Lots / codes
    Batch#: 10072110A2, 10142102A2, Exp 3/22/2022; 01112205A1, 11112123A1, Exp 4/30/2022; 11222114A1, 11172107A1, 11182120A2, Exp 5/7/2022; 01102207A1, 01122211A1, Exp 5/11/2022; 12162119A1, 12162121A1, Exp 5/24/20220; 02022223A2, Exp 6/30/2022; 03012204A1, Exp 8/23/2022; 03082249B, Exp 9/4/2022; 03092226B, 03092236B, Exp 9/5/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    1,856 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1219-2022
  • Class II Ongoing

    Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Product
    Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
    Lots / codes
    Batch #: a)11032122A2, Exp 4/30/2022; 01142226A1, Exp 7/13/2022; b)10272101A1, Exp 4/25/2022; 11292137A1, Exp 5/28/2022; 12142120A2, Exp 6/12/2022; 01042235B, Exp 7/3/2022; 01142226A1, Exp 7/13/2022; 03012240A1, Exp 8/28/2022; 03042223A1, Exp 8/31/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    464 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1218-2022
  • Class II Ongoing

    Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Product
    Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding
    Lots / codes
    Batch#: 03012234A1, Exp 8/28/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    4 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1217-2022
  • Class II Ongoing

    Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Product
    Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
    Lots / codes
    Batch #: a) 10282106A1, Exp 4/26/2022; 11022118A1, Exp 4/30/2022; 12292115A1, Exp 6/27/2022; b)12082113A2, Exp 6/2/2022; 12292115A1, Exp 6/27/2022; 03072230A1, Exp 9/3/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    191 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1216-2022
  • Class II Ongoing

    Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Product
    Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding
    Lots / codes
    Batch#: a)11092114A2, Exp 4/30/2022; 12172113A2, Exp 6/15/2022; 03072227A1, Exp 9/3/2022; b)10122101A2, Exp 4/10/2022; 12022116A1, Exp 5/31/2022; 12292115A1, Exp 6/27/2022; 02222207A1, Exp 8/21/2022; c)10112103A2, Exp 4/9/2022; 11192112A2, Exp 5/18/2022; 12142114A2, Exp 6/12/2022; 12202103A1, Exp 6/18/2022; 12282119A2, Exp 6/26/2022; 01192222A1, Exp 7/18/2022; 02232201A1, Exp 8/22/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    652 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1215-2022
  • Class II Ongoing

    Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room Temperature, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Product
    Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room Temperature, Tailor Made Compounding
    Lots / codes
    Batch#: a) 12092105A2, exp 3/9/2022; 01042219A2, Exp 4/4/2022; 01202210A2, exp 4/20/2022; 01282207A1, exp 4/28/2022; 03032217A1, Exp 6/1/2022; 12092105A2; b) 01282207A1, Exp 4/28/2022; 03032241A1, Exp 6/1/2022
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    232 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1214-2022
  • Class II Ongoing

    Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Product
    Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding
    Lots / codes
    Batch#: a) 01172233A1, Exp 4/17/2022; 01282213A1, Exp 4/28/2022; 02192221A1, Exp 5/20/2022; b)12032118A2, Exp 3/3/2022; 12282120A2, Exp 3/28/2022 01172233A1, Exp 4/17/2022, 01282213A1, Exp 4/28/2022, 02212242A1, Exp 5/22/2022, 03042202A1, Exp 6/2/2022; c) 02192219A1, Exp 5/20/2022; 03062201A1, Exp 6/4/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    924 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1213-2022
  • Class II Ongoing

    Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Lots / codes
    Batch #: a) 01072212A1, Exp 4/7/2022; 03032220A1, Exp 6/1/2022; b) 12162120A2, Exp 3/16/2022; 01142205A1, Exp 4/14/2022; 02012226A1, Exp 5/2/2022; 03032220A1, Exp 6/1/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    182 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1212-2022
  • Class II Ongoing

    Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding · Levocarnitine

    Lots, distribution and details
    Lots / codes
    Batch #: 12022124A2, Exp 3/2/2022; 03032223A1, Exp 6/1/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    12 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1211-2022
  • Class II Ongoing

    Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Lots / codes
    Batch#: 01212203A2, Exp 4/21/2022; 02232213A1, Exp 5/24/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    25 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1210-2022
  • Class II Ongoing

    Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Lots / codes
    Batch #: 01032236A2, Exp 4/3/2022; 03072232A1, Exp 6/5/2022
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    26 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1209-2022
  • Class II Ongoing

    Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding · Hydroxocobalamin

    Lots, distribution and details
    Lots / codes
    Batch#: 12222104A2, Exp 3/22/2022; 01032224A2, Exp 4/3/2022; 01282217A2, Exp 4/28/2022; 02192211A1; Exp 5/20/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    63 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1208-2022
  • Class II Ongoing

    Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Lots / codes
    Batch #: 01062225B, Exp 4/6/2022; 01142207A1, Exp 4/14/2022; 02012228A1, Exp 5/2/2022; 02032203A1, Exp 5/4/2022; 03012211A1, Exp 5/30/2022; 03082240A1, Exp 6/6/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    294 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1207-2022
  • Class II Ongoing

    Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Lots / codes
    Batch #: 12172114A2, Exp 3/17/2022; 01142211A1, Exp 4/14/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    101 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1206-2022
  • Class II Ongoing

    Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Lots / codes
    Batch #: 12062113A2, Exp 3/6/2022; 01052209B, Exp 4/5/2022; 01312223A1, Exp 5/1/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    40 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1205-2022
  • Class II Ongoing

    GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Lots / codes
    Batch #: 10122105A2, Exp 3/20/2022; 01182216A1, Exp 5/31/2022; 02192207A1, Exp 7/31/2022; 03072206A1, Exp 9/3/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    60 Vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1204-2022
  • Class II Ongoing

    GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Lots / codes
    Batch #: 10122110A2, Exp 3/20/2022; 12062110A2, Exp 4/30/2022; 02012202A2, 02192207A1, Exp 7/31/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    90 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1203-2022
  • Class II Ongoing

    Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding · Folic Acid

    Lots, distribution and details
    Product
    Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
    Lots / codes
    Batch#: 10132102A2, Exp 3/22/2022; 01062221B, Exp 4/30/2022; 11302103A1, Exp 4/30/2022; 03032227A1, Exp 8/29/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    45
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1202-2022
  • Class II Ongoing

    Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding · Estradiol Cypionate

    Lots, distribution and details
    Lots / codes
    Batch #: a) 01052210A1, Exp 4/5/2022; 10202101A1, Exp 4/18/2022; 01052210A1 7/4/2022; b)10202102A1, Exp 4/18/2022; 12022126A1, Exp 5/31/2022; 01052210A1, Exp 7/4/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    349 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1201-2022
  • Class II Ongoing

    Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Lots / codes
    Batch#: 01032234A2, Exp 7/2/2022; 02072212A1, Exp 8/6/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    84 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1200-2022
  • Class II Ongoing

    Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Lots / codes
    Batch #: 01032232A1, Exp 7/2/2022; 01242229A2, Exp 7/23/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    19 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1199-2022
  • Class II Ongoing

    Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Lots / codes
    Batch #: a) 12072101A2, Exp 3/7/2022; 01042216A1, Exp 4/4/2022; 02142220A1, Exp 5/15/2022; b)12032129A2, Exp 3/3/2022; 02142220A1, Exp 5/15/2022; 03032213A1, Exp 6/1/2022; 03102214B, Exp 6/8/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    138 vials
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1198-2022
  • Class II Ongoing

    Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding

    Reason: Lack of Assurance of Sterility

    TMC Acquisition LLC dba Tailor Made Compounding

    Lots, distribution and details
    Lots / codes
    Batch #: 12032113A2, Exp 6/1/2022; 01102206A1, Exp 7/9/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    39
    Recall started
    March 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1197-2022

Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.

What the recall classes mean

  • Class I Most serious: use could cause serious health problems or death.
  • Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
  • Class III Not likely to cause health problems — for example a labelling or packaging fault.

Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 5, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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