Phenylephrine HCl Injection — Class I drug recall D-0230-2025
Ongoing recall by Provepharm Inc., reported 2025-02-26, distributed nationwide. Presence of Particulate Matter.
| Recall number | D-0230-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Provepharm Inc., Collegeville, PA, United States |
| Recall initiated | 2025-01-21 |
| Classified | 2025-02-20 |
| Reported by FDA | 2025-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 24,640 vials |
| Reason classes | specification failure |
| Lot numbers | 24020027 |
| Expiration dates | 2025-12-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0230-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.