FDA Class II Recall: Vancomycin HCI, 1.5 grams added to 250 mL,… by Fagron Compounding Services — Recall Details

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Fagron Compounding Services and the affected product is described in FDA's record as: Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01. FDA's stated reason for the recall is: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port. The recall is tracked under FDA recall number D-0441-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01 -- and the recall number D-0441-2026. If it matches, stop using or distributing it and contact Fagron Compounding Services or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Fagron Compounding Services’s FDA history

Argus HQ has recorded 6 total FDA actions tied to Fagron Compounding Services: 0 warning letters, 5 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01) and recall number D-0441-2026, then follow Fagron Compounding Services's recall instructions.

Has Fagron Compounding Services had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 6 total FDA actions tied to Fagron Compounding Services, including 5 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number D-0441-2026.

Related enforcement actions