CLASS II Drug recall · Reported 29 May 2024 · FDA Enforcement Report
Vasopressin Injection, USP per mL) Multiple-Dose Vial recalled
American Regent is recalling Vasopressin Injection, USP per mL) Multiple-Dose Vial, distributed nationwide in the US. The recall was initiated on 13 May 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0507-2024
- FDA event ID
- 94619
- Recalling firm
- American Regent, New Albany, OH
- Brand
- Vasopressin
- Manufacturer
- American Regent, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2024
- FDA classified
- 21 May 2024
- Reported
- 29 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 13 May 2024 | Recall initiated by company | |
| 21 May 2024 | Classified by FDA | +8 days |
| 29 May 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent product in addition to having out-of-specification results for impurities.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Subpotent product in addition to having out-of-specification results for impurities.
Which lots are affected?
Lot #: 23061L1C0, Exp 1/31/2025
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from American Regent
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | ANNOUNCED | Epinephrine Injection, USP 30 mg/ (1 mg/mL) multi dose vial recalledAmerican Regent, Inc. | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Tralement (trace elements injection 4*, USP) recalled by American RegentTralement | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Selenious Acid Injection, USP 12 mcg/ (6 mcg/, For intravenous use recalledSelenious Acid | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid | American Regent | Particulate Matter | Nationwide |
Other Vasopressin recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vasopressin, in 0.9% Sodium Chloride Injection per/mL) recalledVasopressin In 0.9% Sodium Chloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vasopressin, in 0.9% Sodium Chloride Injection per/mL) recalledVasopressin In 0.9% Sodium Chloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vasopressin in 0.9% Sodium Chloride Sterile Syringe recalled | IntegraDose Compounding Services | Potency & Assay | MN |
| Drug | CLASS II | Vasostrict (vasopressin in 5% Dextrose) Injection per mL) recalledVasostrict | Par Sterile Products | Potency & Assay | Nationwide |