Vancomycin HCI recall
FDA recall D-0440-2026 · initiated Mar 20, 2026
Fagron Compounding Services recalled Vancomycin HCI in Mar 2026 — an FDA Class II recall (D-0440-2026) because Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 34,260 bags
Details
- Product
- Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01
- Recalling company
- Fagron Compounding Services
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the U.S.A.
- Initiated
- Mar 20, 2026
- FDA report date
- Apr 15, 2026
Frequently asked
- Was Vancomycin HCI recalled?
- Fagron Compounding Services recalled Vancomycin HCI in Mar 2026 — an FDA Class II recall (D-0440-2026) because Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Vancomycin HCI recalled?
- Per the FDA enforcement record, the reason for recall D-0440-2026 was: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- Is a recalled Vancomycin HCI dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Vancomycin HCI are affected?
- Distributed: Nationwide in the U.S.A.. The recall covers these lots — Lot: 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…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0440-2026.