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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

American Regent Vasopressin Injection Recalled for Subpotency and Impurities

Agency Publication Date: May 21, 2024
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Summary

American Regent, Inc. is recalling 2,352 vials of Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL). The recall was issued because the medication was found to be subpotent, meaning it is not as strong as required, and contained impurities that exceeded safety specifications. This affects 10 mL multiple-dose vials marked with NDC 0517-1030-01, lot number 23061L1C0, and an expiration date of 1/31/2025.

Risk

If the medication is subpotent, it may not provide the intended therapeutic effect, which is critical for patients requiring blood pressure support or intensive care treatment. The presence of impurities beyond allowed limits may also pose additional health risks or side effects.

What You Should Do

  1. This recall affects American Regent Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial (NDC 0517-1030-01) with lot number 23061L1C0 and expiration date 1/31/2025.
  2. Stop using the recalled product. Contact American Regent, Inc. or your distributor to arrange for the return of any remaining vials.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL)
Variants: 20 Units per mL, 10 mL Multiple-Dose Vial, Rx only
Lot Numbers:
23061L1C0 (Exp 1/31/2025)
NDC:
0517-1030-01

Manufactured by American Regent, Inc., Shirley, NY 11967.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94619
Status: Resolved
Manufacturer: American Regent, Inc.
Sold By: Wholesalers; Hospitals; Medical Facilities; Distributors
Manufactured In: United States
Units Affected: 2,352 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.