Why it was recalled
Presence of Particulate Matter.
Product description
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
Lot numbers, UPCs & expiration codes
Lot# 24020027, Exp Date: 12/31/2025
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0230-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jan 21, 2025
- FDA report date
- Feb 26, 2025
- Quantity
- 24640 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Provepharm Inc.
Original FDA data
Every field from FDA enforcement report D-0230-2025, exactly as published.
Show all FDA fields
- City
- Collegeville
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 96121
- Address
- 100 Springhouse Dr Ste 105
- Code information
- Lot# 24020027, Exp Date: 12/31/2025
- Postal code
- 19426-4709
- Report date
- Feb 26, 2025
- Product type
- Drugs
- Recall number
- D-0230-2025
- Classification
- Class I
- Recalling firm
- Provepharm Inc.
- Product quantity
- 24640 vials
- Reason for recall
- Presence of Particulate Matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Jan 21, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 20, 2025