CLASS I ONGOING Drug recall · Reported 26 Feb 2025 · FDA Enforcement Report
Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled
Provepharm is recalling Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials, distributed nationwide in the US. The recall was initiated on 21 Jan 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0230-2025
- FDA event ID
- 96121
- Recalling firm
- Provepharm, Collegeville, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 21 Jan 2025
- FDA classified
- 20 Feb 2025
- Reported
- 26 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Cold & Cough Medicine
Timeline
| 21 Jan 2025 | Recall initiated by company | |
| 20 Feb 2025 | Classified by FDA | +30 days |
| 26 Feb 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter.
Which lots are affected?
Lot# 24020027, Exp Date: 12/31/2025
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Provepharm
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dihydroergotamine Mesylate Injection, solution recalled by ProvepharmDihydroergotamine Mesylate | Provepharm | Other | Nationwide |
Other Phenylephrine recalls
All 122| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine Hydrochloride Injectable Solution, 40mg recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS II | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled | Hikma Injectables USA | Sterility | Nationwide |
| Drug | CLASS I | Phenylephrine in 0.9% Sodium Chloride Injection recalled | Hikma Injectables USA | Labeling Errors | 5 states |
| Drug | CLASS II | Phenylephrine HCl, 1000 mcg/ Total Volume per syringe, Intravenous recalled | SSM Health Care St. Louis | Sterility | MO |