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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

QuVa Pharma Epidural Injection Cassettes Recalled for Sterility Risks

Agency Publication Date: March 25, 2025
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Summary

QuVa Pharma, Inc. has recalled 4,075 cassettes of compounded epidural medications, including Fentanyl Citrate with Bupivacaine or Ropivacaine. These products are being recalled due to a lack of assurance of sterility, which means the medication may not be completely free of microorganisms. The recalled items were distributed nationwide in the United States for institutional and office use.

Risk

Administration of a drug intended for epidural use that lacks sterility assurance poses a serious risk of infection, including meningitis or other life-threatening complications. No injuries or infections have been reported to date.

What You Should Do

  1. This recall affects QuVa Pharma compounded epidural injections including Fentanyl Citrate with Bupivacaine or Ropivacaine, packaged in 100 mL Yellow CADD FSFF cassettes.
  2. Check your inventory for NDC codes 70092-1255-75 and 70092-1259-75.
  3. See the Affected Products section below for the full list of affected lot numbers and expiration dates ranging from April 8, 2025, to April 28, 2025.
  4. Stop using the recalled product. Contact QuVa Pharma, Inc. or your distributor immediately to arrange for the return of any remaining inventory.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: fentaNYL Citrate PF 200 mcg/100 mL / 0.1% Bupivacaine HCl 100 mg/100 mL
Variants: 100 mL in NS Yellow CADD FSFF, Injection for Epidural Use, Compounded
Lot Numbers:
10140259 (Exp 04/24/2025)
10140539 (Exp 04/24/2025)
10140687 (Exp 04/24/2025)
10140688 (Exp 04/24/2025)
NDC:
70092-1255-75

Recall #: D-0295-2025. For Institutional or Office Use Only.

Product: fentaNYL Citrate PF 200 mcg/100 mL / 0.125% Bupivacaine HCl 125 mg/100 mL
Variants: 100 mL in NS Yellow CADD FSFF, Injection for Epidural Use, Compounded
Lot Numbers:
10140284 (Exp 04/08/2025)
10140285 (Exp 04/08/2025)
10140315 (Exp 04/08/2025)
10140316 (Exp 04/08/2025)
10140510 (Exp 04/14/2025)
10140916 (Exp 04/24/2025)
NDC:
70092-1255-75

Recall #: D-0296-2025. Quantity: 2,310 cassettes.

Product: fentaNYL Citrate PF 200 mcg/100 mL / 0.2% ROPivacaine HCl 200 mg/100 mL
Variants: 100 mL in NS Yellow CADD FSFF, Injection for Epidural Use, Compounded
Lot Numbers:
10140303 (Exp 04/14/2025)
10140867 (Exp 04/24/2025)
10140868 (Exp 04/24/2025)
10140965 (Exp 04/28/2025)
NDC:
70092-1259-75

Recall #: D-0297-2025. Quantity: 1,765 cassettes.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96446
Status: Active
Manufacturer: QuVa Pharma, Inc.
Sold By: Institutional Use; Medical Offices; Wholesalers
Manufactured In: United States
Units Affected: 2 products (2,310 cassettes; 1,765 cassettes)
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.