FDA Recalls Vasopressin Injection for Subpotency and Out-of-Specification Impurities
American Regent Inc. is recalling Vasopressin Injection nationwide because some vials are subpotent and contain out-of-specification impurities.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: No illnesses or injuries are reported in the source material. The hazard involves a risk-of-harm medication where injury has not yet been reported, fitting the Score 3 (High) criterion.
Plain-English summary
American Regent Inc. is recalling Vasopressin Injection, USP (20 Units per mL) distributed nationwide. The recall affects 2,352 vials of this 10 mL multiple-dose vial form from lot 23061L1C0 with an expiration date of January 31, 2025.
The product is being recalled because it is subpotent, containing less of the active ingredient than specified on the label. Additionally, the product contains out-of-specification levels of impurities.
Vasopressin is administered by intravenous infusion as a prescription medication. Subpotency or the presence of impurities in this medication could compromise its safety and efficacy.
Healthcare providers and pharmacies should stop using the affected lot immediately and contact American Regent Inc. for guidance on replacement or disposal of the recalled medication.
The recalled product
- Product
- VASOPRESSIN (VASOPRESSIN)
- Brand
- VASOPRESSIN
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injection
- Hazard
- subpotency
- impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 23061L1C0
- Exp 1/31/2025
UPCs (1)
- 0305171030017
Distribution
Distributed nationwide across the United States.
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