American Regent, Inc. 2025-05-07 Health serious FDA
Health · FDA · Recall #FDA-D-0398-2025
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose… Recall
Issued May 7, 2025 · American Regent, Inc.
In May 2025, American Regent, Inc. recalled the niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
What you should do
- 1 Stop using niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact American Regent, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- American Regent, Inc.
- Category
- Health
- Recall date
- May 7, 2025
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0398-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- American Regent, Inc. has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.