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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

    Vitamin 15 (HEMO15) 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
    A5011 Exp 7/10/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-789-2013
  • Class II Ongoing

    Tripelennamine 20 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
    B5620 Exp 8/20/13 and A0322 Exp 12/31/13
    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-788-2013
  • Class II Ongoing

    Trimix, 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
    B5015 Exp 8/15/13, C50001 Exp 8/28/13, B5011 Exp 8/1/13, C42215 Exp 6/22/13, A5028 Exp 6/2/13, B5011 Exp 6/1/13, B5020 Exp 6/1/13, B50112 Exp 8/11/13, C4186 Exp 6/18/13, C4158 Exp 6/15/13, C4149 Exp 6/14/13, C4111 Exp 6/11/13, B4124 Exp 8/12/13, B4154 Exp 8/15/13, B4198 Exp 8/19/13, B4226 Exp 8/22/13, B4268 Exp 8/22/13, C40522 Exp 9/5/13, C4118 Exp 9/1/13, C4711 Exp 9/7/13, C41121 Exp 9/11/13, C4126 Exp 9/12/13 and B42715 Exp 8/27/13.
    Distribution
    Nationwide and PR
    Quantity
    24
    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-787-2013
  • 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
  • Class II Ongoing

    Taurine 100 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
    C5629 Exp 10/31/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-785-2013
  • Class II Ongoing

    Tacrolimus (0.02% and 0.03%) drops, 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
    C51012 Exp 9/12/13 and C51201 Exp 9/6/13
    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-784-2013
  • Class II Ongoing

    Stanozolol (50 mg/ml and 100 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
    50mg/ml = Lots B5727 Exp 8/27/13, and C5708 Exp 9/8/13 // 100,g/ml =Lot C5706 Exp 9/6/13
    Distribution
    Nationwide and PR
    Quantity
    3
    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-783-2013
  • Class II Ongoing

    Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) 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
    0.125% Lot B3505 Exp 8/1/13 // 1% Lots C5001 Exp 9/30/13, C5406 Exp 9/4/13, and C5306 Exp 9/30/13 // 2.5% Lot C5101 Exp 9/30/13 // 3% Lots B5120 Exp 10/31/13, C5301 Exp 9/30/13, B5428 Exp 6/4/13, and C5212 Exp 9/21/13 // 4% Lot C5301 Exp 9/30/13
    Distribution
    Nationwide and PR
    Quantity
    10
    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-782-2013
  • Class II Ongoing

    Sodium Salicylate 40% 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
    B5020 Exp 12/31/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-781-2013
  • Class II Ongoing

    Sodium Iodide 20% 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
    C5822 Exp 9/8/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-780-2013
  • Class II Ongoing

    Sermorelin/GHRP 3 mg/3 mg vial, 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
    A5811 Exp 11/30/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-779-2013
  • Class II Ongoing

    Quadmix, 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
    C4526 Exp 9/4/13, B4125 exp 8/12/13, and B5014 exp 8/1/13
    Distribution
    Nationwide and PR
    Quantity
    3
    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-778-2013
  • Class II Ongoing

    Progesterone EO 100 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
    L3126 Exp 12/31/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-777-2013
  • Class II Ongoing

    Progesterone 100 mg/ml in Olive Oil 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
    B5007 Exp 8/7/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-776-2013
  • Class II Ongoing

    Praziquantel 56.8mg/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 · Praziquantel

    Lots, distribution and details
    Lots / codes
    L3320 Exp 12/31/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-775-2013
  • Class II Ongoing

    Potassium Phosphate 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 · Potassium Phosphate

    Lots, distribution and details
    Lots / codes
    K5019 Exp 9/30/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-774-2013
  • Class II Ongoing

    Polidocanol (0.75%, 1%, 3%, and 10%) 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
    0.75% Lot L5611 Exp 11/30/13 // 1% Lot b3001 Exp 6/19/13, B5014 Exp 8/14/13, and A5431 Exp 6/4/13 // 3% Lot A5808 Exp 12/31/13 // 10% Lot C5328 Exp 9/3/13
    Distribution
    Nationwide and PR
    Quantity
    6
    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-773-2013
  • Class II Ongoing

    Phenylephrine 1 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 · Phenylephrine Hydrochloride

    Lots, distribution and details
    Lots / codes
    L5017 Exp 10/31/13, C51301 Exp 9/30/13, B5312 Exp 8/31/13, and A5209 Exp 11/01/13
    Distribution
    Nationwide and PR
    Quantity
    4
    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-772-2013
  • Class II Ongoing

    Phenylbutazone 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
    A5224 Exp 8/1/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-771-2013
  • Class II Ongoing

    Phentolamine 20 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 · Phentolamine Mesylate

    Lots, distribution and details
    Lots / codes
    B31012 Exp 8/31/13, B5102 Exp 8/10/13, C5228 Exp 9/22/13, B5012 Exp 12/31/13, and C5111 exp 9/11/13
    Distribution
    Nationwide and PR
    Quantity
    5
    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-770-2013
  • Class II Ongoing

    Phenobarbital 62. 5mg/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
    B5128 Exp 8/28/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-769-2013
  • Class II Ongoing

    Pentosan 250 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
    K5629 Exp 11/30/13, C51013 Exp 9/10/13 and C5513 Exp 9/14/13
    Distribution
    Nationwide and PR
    Quantity
    3
    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-768-2013
  • Class II Ongoing

    Pento-Gluc 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
    B0521 Exp 8/21/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-767-2013
  • Class II Ongoing

    PEN-DEX-CHLOR 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
    C5108 Exp 9/10/13
    Distribution
    Nationwide and PR
    Quantity
    1
    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-766-2013
  • Class II Ongoing

    Papaverine 40 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 · Papaverine Hydrochloride

    Lots, distribution and details
    Lots / codes
    B0021 Exp 8/31/13, B0013 Exp 8/1/13, C5122 Exp 9/22/13, C51101 Exp 8/1/13, C5508 Exp 9/8/13, and C5119 Exp 9/19/13
    Distribution
    Nationwide and PR
    Quantity
    6
    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-765-2013

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 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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