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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.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Fagron Sterile Injectable Drugs Recalled for Potential Lack of Sterility

Agency Publication Date: April 7, 2026
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Summary

Fagron Compounding Services is recalling approximately 92,470 bags of sterile injectable drugs, including norepinephrine Bitartrate and Vancomycin HCl. The recall was initiated because of a lack of sterility assurance after discovery that a blue break-off part of the administration port could detach. No incidents or injuries have been reported to date. These products were distributed nationwide to hospitals and healthcare facilities.

Risk

A detached part in the administration port can compromise the sterile seal of the IV bag, potentially leading to a lack of sterility and increasing the risk of serious infection for patients receiving these medications intravenously.

What You Should Do

  1. Identify if you have the recalled norepinephrine Bitartrate (16mg or 32mg) or Vancomycin HCl (1g, 1.25g, or 1.5g) injection bags by checking the NDC codes and lot numbers on the packaging.
  2. Check for affected NDC codes 71266-5026-02, 71266-5027-02, 71266-5083-01, 71266-5085-01, and 71266-5082-01 with expiration dates ranging from April 2026 to July 2026. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact Fagron Compounding Services or your distributor to arrange for the return of any unused product.
  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: norepinephrine Bitartrate, 16mg per 250mL 0.9% Sodium Chloride Injection USP
Variants: 16mg per 250mL
Lot Numbers:
C274-000049934 (Exp.: 4/23/2026)
C274-000049963 (Exp.: 4/24/2026)
C274-000050074 (Exp.: 4/30/2026)
C274-000050123 (Exp.: 5/1/2026)
C274-000050296 (Exp.: 5/9/2026)
C274-000050420 (Exp.: 5/16/2026)
C274-000050774 (Exp.: 6/5/2026)
C274-000050924 (Exp.: 6/7/2026)
C274-000050961 (Exp.: 6/11/2026)
C274-000050991 (Exp.: 6/12/2026)
C274-000051139 (Exp.: 6/19/2026)
C274-000051166 (Exp.: 6/20/2026)
C274-000051198 (Exp.: 6/21/2026)
C274-000051343 (Exp.: 6/28/2026)
NDC:
71266-5026-02

Recall #: D-0438-2026; Quantity: 25,260 bags

Product: norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP
Variants: 32mg per 250mL
Lot Numbers:
C274-000050004 (Exp.: 4/24/2026)
C274-000050295 (Exp.: 5/8/2026)
C274-000050773 (Exp.: 6/4/2026)
C274-000051219 (Exp.: 6/21/2026)
C274-000051318 (Exp.: 6/27/2026)
C274-000051602 (Exp.: 7/12/2026)
NDC:
71266-5027-02

Recall #: D-0439-2026; Quantity: 5,140 bags

Product: Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP
Variants: 1.25 grams per 250 mL
Lot Numbers:
C274-000050857 (Exp.: 7/6/2026)
C274-000049316 (Exp.: 4/26/2026)
C274-000049367 (Exp.: 4/28/2026)
C274-000049496 (Exp.: 5/3/2026)
C274-000049518 (Exp.: 5/4/2026)
C274-000049535 (Exp.: 5/5/2026)
C274-000049653 (Exp.: 5/11/2026)
C274-000049654 (Exp.: 5/11/2026)
C274-000049745 (Exp.: 5/16/2026)
C274-000050128 (Exp.: 5/31/2026)
C274-000050151 (Exp.: 6/1/2026)
C274-000050184 (Exp.: 6/6/2026)
C274-000050504 (Exp.: 6/15/2026)
C274-000050662 (Exp.: 6/21/2026)
C274-000050836 (Exp.: 7/5/2026)
C274-000051014 (Exp.: 7/13/2026)
C274-000051057 (Exp.: 7/18/2026)
C274-000051240 (Exp.: 7/25/2026)
NDC:
71266-5083-01

Recall #: D-0440-2026; Quantity: 34,260 bags

Product: Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP
Variants: 1.5 grams per 250 mL
Lot Numbers:
C274-000050858 (Exp.: 7/6/2026)
C274-000051018 (Exp.: 7/13/2026)
C274-000049194 (Exp.: 4/20/2026)
C274-000049591 (Exp.: 5/9/2026)
C274-000049592 (Exp.: 5/9/2026)
C274-000049823 (Exp.: 5/18/2026)
C274-000050301 (Exp.: 6/8/2026)
C274-000050411 (Exp.: 6/13/2026)
C274-000051056 (Exp.: 7/18/2026)
NDC:
71266-5085-01

Recall #: D-0441-2026; Quantity: 16,130 bags

Product: Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP
Variants: 1 gram per 250 mL
Lot Numbers:
C274-000050987 (Exp.: 7/12/2026)
C274-000049425 (Exp.: 5/2/2026)
C274-000050069 (Exp.: 5/30/2026)
C274-000050346 (Exp.: 6/10/2026)
C274-000050698 (Exp.: 6/27/2026)
C274-000050699 (Exp.: 6/27/2026)
C274-000050775 (Exp.: 7/4/2026)
NDC:
71266-5082-01

Recall #: D-0442-2026; Quantity: 11,680 bags

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98636
Status: Active
Manufacturer: Fagron Compounding Services
Sold By: Hospitals; Healthcare Facilities; Fagron Sterile Services
Manufactured In: United States
Units Affected: 5 products (25,260 bags; 5140 bags; 34,260 bags; 16,130 bags; 11,680 bags)
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.