Phenylephrine HCl Injection recall
FDA recall D-0230-2025 · initiated Jan 21, 2025
Provepharm Inc. recalled Phenylephrine HCl Injection in Jan 2025 — an FDA Class I recall (D-0230-2025) because Presence of Particulate Matter.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of Particulate Matter.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 24640 vials
Details
- 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
- Recalling company
- Provepharm Inc.
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the U.S.
- Initiated
- Jan 21, 2025
- FDA report date
- Feb 26, 2025
Frequently asked
- Was Phenylephrine HCl Injection recalled?
- Provepharm Inc. recalled Phenylephrine HCl Injection in Jan 2025 — an FDA Class I recall (D-0230-2025) because Presence of Particulate Matter. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Phenylephrine HCl Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0230-2025 was: Presence of Particulate Matter.
- Is a recalled Phenylephrine HCl Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Phenylephrine HCl Injection are affected?
- Distributed: Nationwide in the U.S.. The recall covers these lots — Lot# 24020027, Exp Date: 12/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0230-2025.