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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Customceutical Compounding: Various Sterile Injectable Solutions Recalled for Sterility Concerns

Agency Publication Date: April 30, 2019
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Summary

Customceutical Compounding has voluntarily recalled 101 units of various compounded sterile injectable medications, including BPlex, Glutathione, HCG, Lipoplex, Testosterone (Test D and Test PROCYP), and Trimix. These products are being recalled because there is a lack of assurance that the medications are sterile, which can lead to serious infections. These medications were distributed nationwide to patients and clinics in various vial sizes ranging from 2 mL to 12 mL. Patients who have these injectable products should contact their healthcare provider or pharmacist for guidance and stop using the medication immediately.

Risk

If an injectable drug intended to be sterile is contaminated, it can cause life-threatening infections or localized reactions at the site of injection. No specific injuries or infections have been reported to date, but the failure to guarantee sterility poses a significant health risk to patients.

What You Should Do

  1. Immediately stop using any of the affected injectable medications from Customceutical Compounding.
  2. Check your medication vials for the following identifying lot numbers and expiration dates: BPlex 10 mL (Lot 02082019@9, Exp 5/19/19; Lot 03122019@31, Exp 6/10/19), Glutathione 200mg/mL 10/12 mL (Lot 02132019@25, Exp 5/14/19), HCG 5 mL (Lot 03132019@23, Exp 5/12/19), Lipoplex 10 mL (Lot 02212019@13, Exp 5/22/19), Test D 5 mL (Lot 01232019@25, Exp 4/23/19; Lot 03132019@28, Exp 6/11/19), Test PROCYP 5 mL (Lot 03112019@10, Exp 6/19/19), and Trimix (Lots 02182019@27 or 02182019@22, Exp 8/02/19).
  3. Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and to report any adverse health effects.
  4. Return any unused portions of the recalled medication to the pharmacy or place of purchase for a refund.
  5. Contact Customceutical Compounding at 480-516-0272 for further instructions on how to handle the recalled products.
  6. Report any suspected adverse reactions to the FDA's MedWatch program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.
  7. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact healthcare provider and return product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: BPlex (METHYLCOBALAMIN/PYRIDOXAL 5 PHOSPHATE/DEXPANTHENOL) 10 ML MULTIDOSE VIAL
Model:
D-1253-2019
Lot Numbers:
02082019@9 (Exp 5/19/19)
Date Ranges: 5/19/19
Product: BPlex (METHYLCOBALAMIN/PYRIDOXAL 5 PHOSPHATE/DEXPANTHENOL) 10 ML MULTIDOSE VIAL
Model:
D-1254-2019
Lot Numbers:
03122019@31 (Exp 6/10/19)
Date Ranges: 6/10/19
Product: Glutathione 200mg/mL 10 ML and 12 ML MULTIDOSE VIAL
Model:
D-1255-2019
Lot Numbers:
02132019@25 (Exp 5/14/19)
Date Ranges: 5/14/19
Product: HCG (CHORIONIC GONADOTROPIN/PEP) 5 mL MULTIDOSE VIAL
Model:
D-1256-2019
Lot Numbers:
03132019@23 (Exp 5/12/19)
Date Ranges: 5/12/19
Product: Lipoplex (METHIONINE/INOSITOL/CHOLINE/HYDROXOCOBALAMIN/DEXPANTHENOL/PYRIDOXINE) 10 ML MULTIDOSE VIAL
Model:
D-1257-2019
Lot Numbers:
02212019@13 (Exp 5/22/19)
Date Ranges: 5/22/19
Product: Test D (TESTOSTERONE CYPIONATE/VITAMIN D3) 5 ML MULTIDOSE VIAL
Model:
D-1258-2019
Lot Numbers:
01232019@25 (Exp 4/23/19)
Date Ranges: 4/23/19
Product: Test D (TESTOSTERONE CYPIONATE/VITAMIN D3) 5 ML MULTIDOSE VIAL
Model:
D-1259-2019
Lot Numbers:
03132019@28 (Exp 6/11/19)
Date Ranges: 6/11/19
Product: Test PROCYP (TESTOSTERONE CYPIONATE/TESTOSTERONE PROPIONATE) 5 ML MULTIDOSE VIAL
Model:
D-1260-2019
Lot Numbers:
03112019@10 (Exp 6/19/19)
Date Ranges: 6/19/19
Product: Trimix HIGH (Papaverine/Phentolamine/Alprostadil) 2 mL MULTIDOSE VIAL
Model:
D-1261-2019
Lot Numbers:
02182019@27 (Exp 8/02/19)
Date Ranges: 8/02/19
Product: TriMix MEDIUM (Papaverine/Phentolamine/Alprostadil) 2 mL MULTIDOSE VIAL
Model:
D-1262-2019
Lot Numbers:
02182019@22 (Exp 8/02/19)
Date Ranges: 8/02/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82615
Status: Resolved
Manufacturer: Customceutical Compounding
Sold By: Customceutical Compounding; Direct distribution to patients and clinics
Manufactured In: United States
Units Affected: 9 products (32 vials; 19 vials; 4 vials; 12 vials; 16 vials; 8 vials; 2 vials; 5 vials; 3 vials)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.