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

FDA recall notice · announced February 26, 2025 · Provepharm

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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

Reason for recall

Presence of Particulate Matter.

Notes

Distribution: Nationwide in the U.S.
Lot/code information: Lot# 24020027, Exp Date: 12/31/2025
Quantity: 24640 vials
Status: Ongoing
Products in this recall event:
- 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 (D-0230-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.