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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

Fagron, Inc: SyrSpend SF Suspending Base Recalled for Microbial Contamination

Agency Publication Date: February 27, 2018
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Summary

Fagron, Inc. is recalling 1,745 bottles of SyrSpend SF Suspending Base, a liquid vehicle used for compounding prescriptions, because they may be contaminated with yeast and mold. Specifically, the products were found to contain Paecilomyces saturatus and Aspergillus fumigatus. This recall affects both the 500 mL and 4 L sizes of this prescription-only product distributed nationwide across the United States. While no injuries have been reported, using contaminated products can lead to serious infections, especially in vulnerable patients.

Risk

The product is contaminated with mold and yeast species which, if ingested or used in medications, can cause serious infections or respiratory issues, particularly in patients with weakened immune systems or those who are otherwise compromised.

What You Should Do

  1. Check your supply for SyrSpend SF Suspending Base in 500 mL bottles (NDC 51552-1079-5) or 4 L bottles (NDC 51552-1079-9).
  2. Verify if your bottles match the affected lot numbers and expiration: Lot 17I28-U80-039976 for 500 mL bottles or Lot 17I28-U80-039977 for 4 L bottles, both with an expiration date of 10/02/2020.
  3. Immediately stop using any product identified from these affected lots.
  4. Contact your healthcare provider or pharmacist immediately for guidance if you have been using a medication compounded with this base.
  5. Return any unused product to the place of purchase for a refund and contact Fagron, Inc. for further instructions regarding disposal or return.
  6. For further questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: SyrSpend SF Suspending Base (500 mL)
Model:
NDC 51552-1079-5
D-0547-2018
Lot Numbers:
17I28-U80-039976 (exp. 10/02/2020)
Date Ranges: 10/02/2020
Product: SyrSpend SF Suspending Base (4 L)
Model:
NDC 51552-1079-9
D-0547-2018
Lot Numbers:
17I28-U80-039977 (exp. 10/02/2020)
Date Ranges: 10/02/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79253
Status: Resolved
Manufacturer: Fagron, Inc
Manufactured In: United States
Units Affected: a) 1007 bottles (500 mL) and b) 738 bottles (4 L)
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.

Find an Attorney

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 ยท 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.