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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Provepharm Phenylephrine HCl Injection Recalled for Particulate Matter

Agency Publication Date: February 20, 2025
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Summary

Provepharm Inc. has voluntarily recalled 24,640 vials of Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) because of the presence of particulate matter found in the solution. This medication is a Pharmacy Bulk Package intended for intravenous use after dilution. The recall affects lot number 24020027 with an expiration date of 12/31/2025.

Risk

Injecting a drug that contains particulate matter can cause serious health complications, such as inflammation of the blood vessels, the formation of blood clots, or blockages in small blood vessels (embolisms).

What You Should Do

  1. The recalled product is Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) in 10 mL vials (Pharmacy Bulk Package) identified by lot number 24020027 and an expiration date of 12/31/2025.
  2. Stop using the recalled product immediately.
  3. Contact Provepharm Inc. or your medical distributor to arrange for the return of any remaining vials from the affected lot.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls 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: Phenylephrine HCl Injection, USP (100 mg/10 mL)
Variants: 10 mg/mL, 10 mL Vial, Pharmacy Bulk Package
Lot Numbers:
24020027 (Exp Date: 12/31/2025)
NDC:
81284-213-01

Rx Only; Sterile

Product Images

Phenylephrine hydrochloride Injection, USP, 10 mg/ mL single sealed vial; lot number 24020027 and Exp. Date: Dec 2025 (NDC 81284-213-01)

Phenylephrine hydrochloride Injection, USP, 10 mg/ mL single sealed vial; lot number 24020027 and Exp. Date: Dec 2025 (NDC 81284-213-01)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96121
Status: Active
Manufacturer: Provepharm Inc.
Sold By: Medical distributors; Hospitals; Pharmacies
Manufactured In: United States
Units Affected: 24640 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 FDA Press Release 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.