FDA Drug recall D-0230-2025
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Prove…
- FDA Drug
- Class I
- ongoing
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class I recall of Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Prove… by Provepharm, citing presence of Particulate Matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0230-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-01-21 |
| Published | 2025-02-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Provepharm |
| Distribution | US |
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
Presence of Particulate Matter.
Identifiers
| code_info | Lot# 24020027, Exp Date: 12/31/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0230-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.