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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.

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

71 recalls

  • Class II Ongoing

    Testosterone Enanthate (GSO) 100mg/ml, 2 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
    Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding
    Lots / codes
    Batch#: 11102106A1, Exp 4/30/2022; 01142230A1, Exp 7/13/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    93 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-1237-2022
  • Class II Ongoing

    Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 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)11042102A1, Exp 4/30/2022; 12072135A1, Exp 6/5/2022, 01142228A1, Exp 7/13/2022; 02182231A1, Exp 8/17/2022; b)11042102A1, Exp 4/30/2022; 01142228A1, Exp 7/13/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    176 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-1236-2022
  • Class II Ongoing

    Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 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
    Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding
    Lots / codes
    Batch#: a) 10202107A1, Exp 4/18/2022; b) 10142120A2, Exp 4/12/2022; 10272102A1, Exp 4/25/2022 ; 11032117A2, 11102104A2, Exp 4/30/2022; 01252212A2 , Exp 7/24/2022; 02182227A1, Exp 8/17/2022 .
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    246 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-1235-2022
  • Class II Ongoing

    Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 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
    Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial, Room temperature, Tailor Made Compounding
    Lots / codes
    Batch#: Expiry: a) 01142227A1, Exp 7/13/2022; b) 12012126A2, Exp 5/30/2022; 02042203A1, Exp 8/3/2022; c) 01052207A1, Exp 7/4/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    58 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-1234-2022
  • Class II Ongoing

    Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-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)10142123A2, Exp 4/12/2022, 02042202A1, Exp 8/3/2022; b) 10142121A2, Exp 4/12/2022; 10202105A1, Exp 4/18/2022; 11102102A1, Exp 4/30/2022; 02042202A1, Exp 8/3/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    106 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-1233-2022
  • Class II Ongoing

    Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-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#: 11232117A1, Exp 5/22/2022; 01312215A1, Exp 7/30/2022
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    41 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-1232-2022
  • Class II Ongoing

    Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 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)12212105A2, Exp 6/19/2022; 02182229A1, Exp 8/17/2022; b) 12012121A2, Exp 5/30/2022; 12212104A2, Exp 6/19/2022; 01242216A2, Exp 7/23/2022; 02182236A1, Exp 8/17/2022; c) 12072133A1, Exp 6/5/2022; 01192225A1, Exp 7/18/2022; 02182228A1, Exp 8/17/2022; d)10142105A, Exp 4/12/2022; 10272105A1, Exp 4/25/2022; 11102101A1, 11032120A2, Exp 4/30/2022; 11222116A2, Exp 5/21/2022; 12012121A2, Exp 5/30/2022; 12072132A1, Exp 6/5/2022; 12152110A1, Exp 6/13/2022; 12162118A1, Exp 6/14/2022; 12212103A2, Exp 6/19/2022; 01052206A1, Exp 7/4/2022; 01142229A1, Exp 7/13/2022; 01212207A2 Exp, 7/20/2022; 02042201A1, Exp 8/3/2022; 02182226A1, Exp 8/17/2022; 02252224A1, 02252226A1, Exp 8/24/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    4,219 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-1231-2022
  • Class II Ongoing

    Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 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#: a) 12212109A2, Exp 6/19/2022; 01312217A1, Exp 7/30/2022; b) 10202108A1, Exp 4/18/2022; 12012125A, Exp 5/30/2022 ;02182230A1, Exp 8/17/2022; 10202108A1; 03022222A1, Exp 8/29/2022.
    Distribution
    Nationwide USA and Puerto Rico
    Quantity
    273 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-1230-2022
  • Class II Ongoing

    Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 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 #: 10182113A1, Exp 4/16/2022.
    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-1194-2022
  • Class II Ongoing

    Testosterone Propionate 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy · Testosterone

    Lots, distribution and details
    Product
    Testosterone Propionate 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07272016A (01/23/2017), 07052016A (12/31/2016), 11072016A (05/06/2017).
    Distribution
    Nationwide
    Quantity
    347 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0307-2017
  • Class II Ongoing

    Testosterone Suspension 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy · Testosterone

    Lots, distribution and details
    Product
    Testosterone Suspension 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06292016C (10/28/2016).
    Distribution
    Nationwide
    Quantity
    13 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0306-2017
  • Class II Ongoing

    Testosterone Enanthate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Enanthate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016C (11/19/2016), 08122016A (02/28/2017), 11012016J (04/30/2017), 07132016G (01/09/2017), 09012016B (02/28/2017), 09272016A (03/26/2017).
    Distribution
    Nationwide
    Quantity
    1,567 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0305-2017
  • Class II Ongoing

    Testosterone Cypionate/Enanthate/Propionate, 160 mg/20 mg/20 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate/Enanthate/Propionate, 160 mg/20 mg/20 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06082016C (11/09/2016), 07222016B (01/18/2017), 09012016A (02/28/2017), 06012016C (11/09/2016), 08042016E (01/31/2017), 10032016A (04/01/2017).
    Distribution
    Nationwide
    Quantity
    882 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0304-2017
  • Class II Ongoing

    Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07132016D (01/09/2017), 11072016B (05/06/2017).
    Distribution
    Nationwide
    Quantity
    152 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0303-2017
  • Class II Ongoing

    Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06272016A (12/24/2016), 08242016A (02/20/2017), 09212016B (03/20/2017), 07252016A (01/21/2017), 08112016B (02/07/2017), 10252016L (02/28/2017).
    Distribution
    Nationwide
    Quantity
    1,244 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0302-2017
  • Class II Ongoing

    Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07262016A (01/22/2017), 07132016C (01/09/2017), 08302016A (02/26/2017), 08042016D (01/31/2017), 11012016K (04/30/2017), 09202016D (03/19/2017), 10032016B (04/01/2017), 08102016A (02/06/2017), 09282016D (03/27/2017), 09222016E (03/21/2017), 09152016A (02/28/2017), 09062016B (02/28/2017), 10252016C (02/28/2017), 10042016E (04/02/2017).
    Distribution
    Nationwide
    Quantity
    1,544 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0301-2017
  • Class II Ongoing

    Testosterone Cypionate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05252016A (11/21/2016), 06272016B (12/24/2016), 07262016D (01/22/2017), 07182016H (01/14/2017), 07182016G (01/14/2017), 08252016C (02/21/2017), 08222016B (02/18/2017), 08102016A (02/06/2017), 09282016D (03/27/2017), 09222016E (03/21/2017), 09152016A (02/28/2017), 09062016B (02/28/2017), 10252016C (02/28/2017), 10042016E (04/02/2017).
    Distribution
    Nationwide
    Quantity
    7,168 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0300-2017
  • Class II Ongoing

    Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016D (11/19/2016), 06162016A (12/13/2016), 06132016A (12/10/2016), 07282016I (01/24/2017), 08172016D (02/13/2017), 08042016C (01/31/2017), 09222016F (03/21/2017), 09062016A (02/28/2017), 10272016B (02/28/2017), 10252016D (02/28/2017), 08252016B (02/21/2017), 11022016C (05/01/2017).
    Distribution
    Nationwide
    Quantity
    2,818 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0299-2017
  • Class II Ongoing

    Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05122016B (11/18/2016), 08012016C (01/28/2017), 09262016D (03/25/2017).
    Distribution
    Nationwide
    Quantity
    400 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0298-2017
  • Class II Ongoing

    Testosterone Cypionate in Sesame, 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate in Sesame, 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07152016A (01/11/2017), 08182016A (02/14/2017), 09282016J (03/27/2017).
    Distribution
    Nationwide
    Quantity
    166 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0297-2017
  • Class II Ongoing

    Testosterone Cypionate (100 mg/ml & 200 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL

    Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

    Lowlite Investments, Inc. D/B/A Olympia Pharmacy

    Lots, distribution and details
    Lots / codes
    A5016 Exp 12/31/13 and B5028 6/5/13
    Distribution
    Nationwide and PR
    Quantity
    2
    Recall started
    May 29, 2013 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-786-2013

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 October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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