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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

US Compounding Inc: Ephedrine Sulfate Syringes Recalled for Lack of Sterility Assurance

Agency Publication Date: February 15, 2019
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Summary

US Compounding Inc is recalling 1,686 syringes of Ephedrine Sulfate (50 mg/10 mL), a prescription medication used to treat low blood pressure during anesthesia. The recall was initiated because the manufacturer cannot ensure the product is sterile, which is a critical requirement for injectable medications. Consumers who have these syringes should contact their healthcare provider or pharmacist immediately, as the use of a non-sterile injectable product can lead to serious infections.

Risk

If an injectable drug is not sterile, it may contain bacteria or other microorganisms that can cause life-threatening infections or sepsis when administered directly into the bloodstream. No specific injuries have been reported at the time of this recall.

What You Should Do

  1. Check your medical supplies for Ephedrine Sulfate 50 mg/10 mL (10 mL Single Use Syringes) labeled with US Compounding Pharmacy.
  2. Verify if your product matches Lot number 20181812 with a 'Beyond Use Date' (BUD) of 06/16/2019.
  3. Look for the barcode number 62295308407 on the syringe packaging to confirm it is part of the recall.
  4. Immediately stop using any syringes from the affected lot and contact your healthcare provider or pharmacist for guidance on alternative treatments.
  5. Return any unused syringes from this lot to the pharmacy where they were obtained for a refund.
  6. Contact US Compounding Inc at 800-718-3588 if you have further questions regarding this recall.
  7. For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmaceutical product refund and healthcare consultation.

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

Affected Products

Product: Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe
Model:
Recall #: D-0508-2019
UPC Codes:
62295308407
Lot Numbers:
20181812 (BUD: 06/16/2019)
20181812@2
Date Ranges: 06/16/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82012
Status: Resolved
Manufacturer: US Compounding Inc
Sold By: US Compounding Pharmacy
Manufactured In: United States
Units Affected: 1686 syringes
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.