Vasopressin Injection recall
FDA recall D-0507-2024 · initiated May 13, 2024
American Regent, Inc. recalled Vasopressin Injection in May 2024 — an FDA Class II recall (D-0507-2024) because Subpotent product in addition to having out-of-specification results for impurities.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent product in addition to having out-of-specification results for impurities.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 2,352 vials
Details
- Product
- Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
- Recalling company
- American Regent, Inc.
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- May 13, 2024
- FDA report date
- May 29, 2024
Frequently asked
- Was Vasopressin Injection recalled?
- American Regent, Inc. recalled Vasopressin Injection in May 2024 — an FDA Class II recall (D-0507-2024) because Subpotent product in addition to having out-of-specification results for impurities. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Vasopressin Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0507-2024 was: Subpotent product in addition to having out-of-specification results for impurities.
- Is a recalled Vasopressin Injection 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 Vasopressin Injection are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot #: 23061L1C0, Exp 1/31/2025. 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-0507-2024.