Recall archive / 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. Source coverage and dates.

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

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

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.