FDAClass IFebruary 26, 2025

Phenylephrine HCl Injection recall: Particulate Matter

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…

Why was Phenylephrine HCl Injection recalled?

Presence of Particulate Matter.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Provepharm Inc.
Quantity
24640 vials
Distribution
Nationwide in the U.S.
Recall date
February 26, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls