FDA Drugs recall ·
Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0230-2025
- Date
- (initiated January 21, 2025)
- Company / brand
- Provepharm Inc.
100 Springhouse Dr Ste 105, Collegeville, PA, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 24640 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Presence of Particulate Matter.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# 24020027, Exp Date: 12/31/2025
Distribution
Nationwide in the U.S.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0230-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.