Provepharm Inc. drug recall: Phenylephrine HCl Injection
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 96121
- Recall initiated
- Jan 21, 2025
- Classified by FDA
- Feb 20, 2025
- Posted in Enforcement Report
- Feb 26, 2025
- Recalling firm
- Provepharm Inc.
- Firm location
- Collegeville, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Presence of Particulate Matter.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jan 21, 2025. FDA classified it 30 days later, on Feb 20, 2025. Distribution reported by FDA: Nationwide in the U.S. Provepharm Inc. has 2 recalls in our records.
Recalled products (1)
D-0230-2025 Class I Ongoing
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
Codes / lots: Lot# 24020027, Exp Date: 12/31/2025
Quantity: 24640 vials
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 96121
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.