FDA Recall D-0230-2025

Provepharm Inc. · Collegeville, PA

Class I — life-threatening Ongoing 478 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

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

Quantity: 24640 vials

Reason for recall

Presence of Particulate Matter.

Recall record

Recall number: D-0230-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the U.S.
Recall initiated: 2025-01-21
Classified by FDA Center: 2025-02-20
FDA published: 2025-02-26
Recalling firm: Provepharm Inc.
Firm location: Collegeville, PA

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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