Class I — UrgentReported 2025-02-26

Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426

Recalled by Provepharm Inc.

Reason for Recall

Presence of Particulate Matter.

Recall Number

D-0230-2025

Classification

Class I

Status

Ongoing

Category

drug

Initiated

2025-01-21

Reported

2025-02-26

Distribution

Nationwide in the U.S.

Code Info

Lot# 24020027, Exp Date: 12/31/2025

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.