---
title: "Provepharm Inc.: Phenylephrine hydrochloride Injection, USP, 10 mg/ mL — FDA announcement Jan 24, 2025 | Is It on Recall"
description: "Device & Drug Safety – Potential Foreign Material"
url: https://isitonrecall.com/recall/fdapress-7937679c4b5a43a3-provepharm-inc-phenylephrine-hydrochloride-injection-usp-10-mg-ml/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# Provepharm Inc.: Phenylephrine hydrochloride Injection, USP, 10 mg/ mL — FDA announcement Jan 24, 2025

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jan 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Phenylephrine hydrochloride Injection, USP, 10 mg/ mL
- **Reason**: Device & Drug Safety – Potential Foreign Material
- **Classification**: Not supplied
- **Recalling firm**: Provepharm Inc.
- **Quantity**: Not supplied
- **Agency-reported status**: Company recall announcement
- **Source record identifier**: 7937679c4b5a43a3

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/provepharm-inc-issues-voluntary-nationwide-recall-one-lot-phenylephrine-hydrochloride-injection-usp)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | FOR IMMEDIATE RELEASE – January 24, 2025 – Collegeville, Pennsylvania, Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) at the hospital/institutional level. This recall was initiated based on a customer complaint from a pharmacy after observing a visible black particulate matter found in a single-sealed vial of the product.; The product can be identified by product name on carton and vial label and with lot number 24020027 and Exp. Date: Dec 2025 (NDC 81284-213-01) (See enclosed vial label).; Wholesalers, distributors, compounding companies and hospitals in procession of the recalled Phenylephrine hydrochloride Injection, USP, 10 mg/ mL lot number 24020027, Exp date December 2025, should immediately cease use of and return the product to Sedgwick at the following address |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Jan 24, 2025
- **Company announcement date**: Jan 24, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Customers with questions regarding this recall can contact from 8:00 am to 5:00 pm (EST) Monday - Friday at: Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/provepharm-inc-issues-voluntary-nationwide-recall-one-lot-phenylephrine-hydrochloride-injection-usp)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Provepharm Inc. records](https://isitonrecall.com/brand/provepharm-inc/)