Why it was recalled
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Product description
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Lot numbers, UPCs & expiration codes
Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;
Where it was sold
Nationwide in the USA
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-0399-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 18, 2025
- FDA report date
- May 7, 2025
- Quantity
- 7,249 (cartons of 10 x 10 mL vials)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Regent, Inc.
Original FDA data
Every field from FDA enforcement report D-0399-2025, exactly as published.
Show all FDA fields
- City
- New Albany
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 96695
- Address
- 6610 New Albany Rd E
- Code information
- Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;
- Postal code
- 43054-8730
- Report date
- May 7, 2025
- Product type
- Drugs
- Recall number
- D-0399-2025
- Classification
- Class II
- Recalling firm
- American Regent, Inc.
- Product quantity
- 7,249 (cartons of 10 x 10 mL vials)
- Reason for recall
- Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 18, 2025
- Initial firm notification
- Letter
- Center classification date
- May 1, 2025