Recalls / Class I
Class ID-0230-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot# 24020027, Exp Date: 12/31/2025
Why it was recalled
Presence of Particulate Matter.
Recalling firm
- Firm
- Provepharm Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Springhouse Dr Ste 105, N/A, Collegeville, Pennsylvania 19426-4709
Distribution
- Quantity
- 24640 vials
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2025-01-21
- FDA classified
- 2025-02-20
- Posted by FDA
- 2025-02-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0230-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.