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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

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical: Various Sterile Injectable Medications Recalled for Sterility Concerns

Agency Publication Date: March 5, 2020
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Summary

Fusion IV Pharmaceuticals (Axia Pharmaceutical) is voluntarily recalling numerous lots of various sterile injectable drug products, including Alprostadil, Betamethasone, Cyanocobalamin, and Testosterone, because they may not be sterile. The lack of sterility assurance was discovered following an FDA inspection of the manufacturing facility. While no injuries or infections have been reported to date, using a non-sterile injectable medication can lead to serious, life-threatening infections. These prescription-only medications were distributed nationwide across the U.S. and to several international locations.

Risk

Injecting a product that lacks sterility assurance can introduce bacteria or fungi directly into the body, potentially causing severe systemic infections or abscesses. This risk is especially high for patients with weakened immune systems who may be unable to fight off such infections.

What You Should Do

  1. Check your medication packaging for 'Axia Pharmaceutical' and the specific product names, NDC numbers, and lot numbers listed in this recall.
  2. Verify if you have any affected vials, such as Alprostadil (Lot 12042019), AscorbiX (Lots 07112019, 08222019), or Testosterone Cypionate (Lots 03252019, 03062019), among many others listed.
  3. Stop using the affected medication immediately and do not administer any further doses from the recalled lots.
  4. Contact your healthcare provider or pharmacist immediately if you have used any of these products and are experiencing unusual symptoms or signs of infection.
  5. Return any unused vials to the pharmacy where you purchased them for a refund and contact Axia Pharmaceutical at 1-888-723-3332 for further instructions on the return process.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-SAFEFDA (1-888-723-3332) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection (2.5 mL)
Model:
NDC 71283-0547-2
Lot Numbers:
12042019+533247 (Exp 1/17/2020)
12042019
Date Ranges: Exp 1/17/2020
Product: Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection (2.5 mL)
Model:
NDC 71283-0549-2
Lot Numbers:
12042019+533225 (Exp 1/17/2020)
12042019
Date Ranges: Exp 1/17/2020
Product: AscorbiX (Buffered C) Injection (30 mL)
Model:
NDC 71283-0226-3
Lot Numbers:
07112019+52635 (Exp 1/17/2020)
09092019+52890 (Exp 3/17/2020)
07112019
Date Ranges: Exp 1/17/2020, Exp 3/17/2020
Product: B-COMPLEX 110 INJECTABLE (30 mL)
Model:
NDC 71283-0212-3
Lot Numbers:
07022019+52584 (Exp 3/29/2020)
07022019+52579 (Exp 3/29/2020)
08012019+52780 (Exp 4/28/2020)
11262019+53288 (Exp 8/23/2020)
Date Ranges: Exp 3/29/2020, Exp 4/28/2020, Exp 8/23/2020
Product: BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension (2 mL)
Model:
NDC 71283-0620-2
Lot Numbers:
10022019+53004 (Exp 2/28/2020)
11252019+53282 (Exp 6/12/2020)
Date Ranges: Exp 2/28/2020, Exp 6/12/2020
Product: Cyanocobalamin Injection (30 mL)
Model:
NDC 71283-0330-3
Lot Numbers:
07172019+52695 (Exp 1/25/2020)
07172019+52697 (Exp 1/25/2020)
07252019+52759 (Exp 1/25/2020)
Date Ranges: Exp 1/25/2020
Product: Glutathione Injection (30 mL)
Model:
NDC 71283-1231-3
Lot Numbers:
10212019+53138 (Exp 11/19/2020)
10302019+53172 (Exp 1/28/2020)
11122019+53225 (Exp 2/10/2020)
Date Ranges: Exp 11/19/2020, Exp 1/28/2020, Exp 2/10/2020
Product: Human Chorionic Gonadotropin (hCG) Injection (10 mL)
Model:
NDC 71283-0533-1
Lot Numbers:
07222019+52720 (Exp 1/28/2020)
09182019+52923 (Exp 3/26/2020)
10232019+53148 (Exp 2/28/2020)
11142019+53243 (Exp 5/22/2020)
Date Ranges: Exp 1/28/2020, Exp 3/26/2020, Exp 2/28/2020, Exp 5/22/2020
Product: Testosterone Cypionate Injection (10 mL)
Model:
NDC 71283-0530-1
Lot Numbers:
03252019+51850 (Exp 7/6/2020)
04252019+52098 (Exp 6/29/2020)
04292019+52108 (Exp 6/29/2020)
07082019+52594 (Exp 12/29/2020)
09112019+52905 (Exp 1/18/2021)
Date Ranges: Exp 7/6/2020, Exp 6/29/2020, Exp 12/29/2020, Exp 1/18/2021
Product: Triamcinolone Acetonide (PF) Injectable Suspension (2 mL)
Model:
NDC 71283-0635-2
Lot Numbers:
08272019+52841 (Exp 2/22/2020)
09242019+52953 (Exp 3/22/2020)
11122019+53223 (Exp 5/10/2020)
Date Ranges: Exp 2/22/2020, Exp 3/22/2020, Exp 5/10/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84978
Status: Resolved
Manufacturer: Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Sold By: Direct distribution; Axia Pharmaceutical
Manufactured In: United States
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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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.