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Drug FDA Class I Ongoing Foreign material

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

Provepharm Inc. Published Feb 26, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Provepharm Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of Particulate Matter.

Hazards

Particulate Matter · primary

Affected products (1)

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

24640 vials

Lot codes: 24020027
Code info: Lot# 24020027, Exp Date: 12/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 21, 2025
  2. Published
    Feb 26, 2025
Recall number
D-0230-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.